Clinical Trial Details
| Trial ID: | L1606 |
| Source ID: | NCT02879305 |
| Associated Drug: | Daprodustat |
| Title: | Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D) |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02879305/results |
| Conditions: | Anaemia|Aspergillosis, Allergic Bronchopulmonary |
| Interventions: | DRUG: Daprodustat|DRUG: rhEPO|DRUG: Placebo|DRUG: Iron therapy |
| Outcome Measures: | Primary: Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period: Non-inferiority Analysis, Time to MACE defined as the time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \[MI\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied by \[\*\] number of participants with at least 1 event) divided by \[/\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Mean Change From Baseline in Hemoglobin (Hgb) Levels During Evaluation Period (Week 28 to Week 52), Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52) | Secondary: Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period: Superiority Analysis, Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Up to 3.9 person-years for CV follow-up time period|Mean Average Monthly On-treatment IV Iron Dose Per Participant, Average monthly IV iron dose (milligrams) per participant from Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from treatment start date + 1 to the earliest of (Week 52 visit date, first blood (red blood cell \[RBC\] or whole blood) transfusion date, and treatment stop date + 1 day) which corresponds to the time while the participant was on randomized treatment and before receiving a blood transfusion. This total IV iron dose was divided by (the number of days from treatment start date + 1 to the earliest of (Week 52 visit date, first blood transfusion date (RBC or whole blood), and treatment stop date +1) / 30.4375 days). This endpoint was adjusted for multiplicity using the Holm-Bonferonni method., Day 1 to Week 52|Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period, Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status for follow-up time period., Up to 3.9 person-years for vital status follow-up time period|Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period, Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period, Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis), Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period, Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period, All-cause hospitalization events were hospital admissions recorded on the Hospitalization electronic case report form (eCRF) with a hospitalization duration \>=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period, All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization eCRF with hospitalization duration of \>=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was \>=24 hours. Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. Incidence rate per 100person years calculated as(100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period, Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period, Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period, Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, dialysis type and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period., Up to 3.9 person-years for CV follow-up time period|Change From Baseline in Post-randomization Hemoglobin Levels at Week 52, Blood samples were collected from participants for hemoglobin measurements. Change from Baseline was defined as post-Baseline value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, dialysis type, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interactions., Baseline (Pre-dose on Day 1) and Week 52|Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52), Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hemoglobin responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL., Week 28 to Week 52|Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\]., Week 28 to Week 52|Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\]., Week 28 to Week 52|Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\]., Week 28 to end of study (3.9 person-years for follow-up time period)|Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis, Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\]., Week 28 to end of study (3.9 person-years for follow-up time period)|Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52, SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is the average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + dialysis type + region + Baseline value + Baseline value\*time + treatment group\*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented., Baseline (Week -4) and Week 52|Change From Baseline in SBP, DBP, MAP at End of Treatment, SBP, DBP and MAP were measured in a semi-supine or seated position in the dialysis chair after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. This analysis was carried out by using ANCOVA model with terms for treatment group, dialysis type, region and Baseline value. Data for post-dialysis BP measurements have been presented., Baseline (Week -4) and 45.1 months|Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years, BP exacerbation was defined (based on post-dialysis) as: SBP \>= 25 millimeter of mercury (mmHg) increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the negative binomial model with treatment, dialysis type and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented., Day 1 to end of study (3.9 person-years for follow-up time period)|Number of Participants With at Least One BP Exacerbation Event During Study, BP exacerbation was defined as: SBP \>= 25 mmHg increased from Baseline or SBP \>=180 mmHg; DBP \>=15 mmHg increased from Baseline or DBP \>=110 mmHg. Number of participants with at least one BP exacerbation event is presented., Day 1 to end of study (3.9 person-years for follow-up time period)|Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria, Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented., Day 1 to 45.1 months|Change From Baseline in On-Treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-Treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-Treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain, general health, mental health, role-emotional (role limitations caused by emotional problems), role-physical (role limitations caused by physical problems), social functioning (Social fun), physical functioning (Phy. fun) and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-Treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-Treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52, The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52|Change From Baseline in On-Treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52, EQ-5D-5L is self-assessment questionnaire,consisting of 5 items covering 5 dimensions (mobility,self care,usual activities,pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value-Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date., Baseline (Pre-dose on Day 1) and Week 52|Change From Baseline in On-Treatment EuroQol Visual Analogue Scale (EQ-VAS) at Week 52, The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst health one can imagine and 100 represents the best health one can imagine. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1) and Week 52|Change From Baseline in On-Treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52, The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated worse outcome. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date., Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52 |
| Sponsor/Collaborators: | Sponsor: GlaxoSmithKline |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 2964 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2016-09-28 |
| Completion Date: | 2020-11-09 |
| Results First Posted: | 2021-12-03 |
| Last Update Posted: | 2021-12-03 |
| Locations: | GSK Investigational Site, Huntsville, Alabama, 35805, United States|GSK Investigational Site, Pine Bluff, Arkansas, 71603, United States|GSK Investigational Site, Anaheim, California, 92801, United States|GSK Investigational Site, Bakersfield, California, 93308, United States|GSK Investigational Site, Bakersfield, California, 93309, United States|GSK Investigational Site, Beverly Hills, California, 90211, United States|GSK Investigational Site, Cerritos, California, 90703, United States|GSK Investigational Site, Chula Vista, California, 91910, United States|GSK Investigational Site, El Centro, California, 92243, United States|GSK Investigational Site, Escondido, California, 92025, United States|GSK Investigational Site, Fairfield, California, 94534, United States|GSK Investigational Site, Fountain Valley, California, 92708, United States|GSK Investigational Site, Glendale, California, 91205, United States|GSK Investigational Site, Granada Hills, California, 91344, United States|GSK Investigational Site, Hacienda Heights, California, 91745, United States|GSK Investigational Site, La Mesa, California, 91942, United States|GSK Investigational Site, La Palma, California, 90623, United States|GSK Investigational Site, Lakewood, California, 90712, United States|GSK Investigational Site, Long Beach, California, 90806, United States|GSK Investigational Site, Long Beach, California, 90807, United States|GSK Investigational Site, Long Beach, California, 90813, United States|GSK Investigational Site, Los Angeles, California, 90022, United States|GSK Investigational Site, Los Angeles, California, 90095, United States|GSK Investigational Site, Lynwood, California, 60262, United States|GSK Investigational Site, Montebello, California, 90640, United States|GSK Investigational Site, Monterey Park, California, 91754, United States|GSK Investigational Site, Moreno Valley, California, 92553, United States|GSK Investigational Site, Norco, California, 92860, United States|GSK Investigational Site, Northridge, California, 91324, United States|GSK Investigational Site, Ontario, California, 91762, United States|GSK Investigational Site, Riverside, California, 92501, United States|GSK Investigational Site, Sacramento, California, 95825, United States|GSK Investigational Site, San Diego, California, 92103, United States|GSK Investigational Site, San Diego, California, 92111, United States|GSK Investigational Site, San Luis Obispo, California, 93405, United States|GSK Investigational Site, Santa Clarita, California, 91387, United States|GSK Investigational Site, Simi Valley, California, 93065-091, United States|GSK Investigational Site, Tarzana, California, 91356, United States|GSK Investigational Site, Whittier, California, 90602, United States|GSK Investigational Site, Whittier, California, 90603, United States|GSK Investigational Site, Yorba Linda, California, 92886, United States|GSK Investigational Site, Middlebury, Connecticut, 06762, United States|GSK Investigational Site, Washington, District of Columbia, 20037, United States|GSK Investigational Site, Aventura, Florida, 33180, United States|GSK Investigational Site, Coral Gables, Florida, 33134, United States|GSK Investigational Site, Hollywood, Florida, 33024, United States|GSK Investigational Site, Jacksonville, Florida, 32224, United States|GSK Investigational Site, Lauderdale Lakes, Florida, 33313, United States|GSK Investigational Site, Miami Gardens, Florida, 33169, United States|GSK Investigational Site, Miami, Florida, 33126, United States|GSK Investigational Site, Miami, Florida, 33143, United States|GSK Investigational Site, Miami, Florida, 33150, United States|GSK Investigational Site, Miami, Florida, 33156, United States|GSK Investigational Site, Ocala, Florida, 34471, United States|GSK Investigational Site, Port Charlotte, Florida, 33952, United States|GSK Investigational Site, Spring Hill, Florida, 34608, United States|GSK Investigational Site, Winter Park, Florida, 32789, United States|GSK Investigational Site, Augusta, Georgia, 30904, United States|GSK Investigational Site, Augusta, Georgia, 30912, United States|GSK Investigational Site, Columbus, Georgia, 31904, United States|GSK Investigational Site, Meridian, Idaho, 83642, United States|GSK Investigational Site, Crystal Lake, Illinois, 60014, United States|GSK Investigational Site, Fort Wayne, Indiana, 46804, United States|GSK Investigational Site, Jeffersonville, Indiana, 47130, United States|GSK Investigational Site, Merrillville, Indiana, 46410, United States|GSK Investigational Site, Michigan City, Indiana, 46360, United States|GSK Investigational Site, Iowa City, Iowa, 52242, United States|GSK Investigational Site, Louisville, Kentucky, 40202, United States|GSK Investigational Site, Baton Rouge, Louisiana, 70808, United States|GSK Investigational Site, Baton Rouge, Louisiana, 70836, United States|GSK Investigational Site, Greenbelt, Maryland, 20770, United States|GSK Investigational Site, Takoma Park, Maryland, 20912-6385, United States|GSK Investigational Site, Kalamazoo, Michigan, 49007, United States|GSK Investigational Site, Pontiac, Michigan, 48341, United States|GSK Investigational Site, Roseville, Michigan, 48066, United States|GSK Investigational Site, Gulfport, Mississippi, 39501, United States|GSK Investigational Site, Tupelo, Mississippi, 38801, United States|GSK Investigational Site, Florissant, Missouri, 63033, United States|GSK Investigational Site, Kansas City, Missouri, 64111, United States|GSK Investigational Site, Saint Louis, Missouri, 63110, United States|GSK Investigational Site, Las Vegas, Nevada, 89102, United States|GSK Investigational Site, Las Vegas, Nevada, 89107, United States|GSK Investigational Site, Portsmouth, New Hampshire, 3801, United States|GSK Investigational Site, Gallup, New Mexico, 87301, United States|GSK Investigational Site, Bronx, New York, 10461, United States|GSK Investigational Site, Brooklyn, New York, 11203, United States|GSK Investigational Site, Buffalo, New York, 14215, United States|GSK Investigational Site, Flushing, New York, 11355, United States|GSK Investigational Site, Mineola, New York, 11501, United States|GSK Investigational Site, New York, New York, 10029, United States|GSK Investigational Site, Ridgewood, New York, 11385, United States|GSK Investigational Site, Yonkers, New York, 10710, United States|GSK Investigational Site, Asheville, North Carolina, 28801, United States|GSK Investigational Site, Clyde, North Carolina, 28721, United States|GSK Investigational Site, Raleigh, North Carolina, 27609, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27103, United States|GSK Investigational Site, Winston-Salem, North Carolina, 27517, United States|GSK Investigational Site, Canton, Ohio, 44718, United States|GSK Investigational Site, Cincinnati, Ohio, 45206, United States|GSK Investigational Site, Cincinnati, Ohio, 45220, United States|GSK Investigational Site, Roseburg, Oregon, 97471, United States|GSK Investigational Site, Bethlehem, Pennsylvania, 18017, United States|GSK Investigational Site, Philadelphia, Pennsylvania, 19140, United States|GSK Investigational Site, Providence, Rhode Island, 02903, United States|GSK Investigational Site, Anderson, South Carolina, 29621, United States|GSK Investigational Site, Charleston, South Carolina, 29425, United States|GSK Investigational Site, Sumter, South Carolina, 29150, United States|GSK Investigational Site, Cordova, Tennessee, 38018, United States|GSK Investigational Site, Knoxville, Tennessee, 37923, United States|GSK Investigational Site, Knoxville, Tennessee, 37924, United States|GSK Investigational Site, Nashville, Tennessee, 37205, United States|GSK Investigational Site, Beaumont, Texas, 77701, United States|GSK Investigational Site, Houston, Texas, 77004, United States|GSK Investigational Site, Houston, Texas, 77030, United States|GSK Investigational Site, Houston, Texas, 77099, United States|GSK Investigational Site, Lufkin, Texas, 75904, United States|GSK Investigational Site, San Antonio, Texas, 78207, United States|GSK Investigational Site, San Antonio, Texas, 78221, United States|GSK Investigational Site, San Antonio, Texas, 78251, United States|GSK Investigational Site, San Antonio, Texas, 78258, United States|GSK Investigational Site, Alexandria, Virginia, 22304, United States|GSK Investigational Site, Fairfax, Virginia, 22033, United States|GSK Investigational Site, Hampton, Virginia, 23666, United States|GSK Investigational Site, Salem, Virginia, 24153, United States|GSK Investigational Site, Bluefield, West Virginia, 24701, United States|GSK Investigational Site, Shorewood, Wisconsin, 53211, United States|GSK Investigational Site, Burzaco, Buenos Aires, B1852FZD, Argentina|GSK Investigational Site, Ciudad Evita, Buenos Aires, B1778IFA, Argentina|GSK Investigational Site, Pergamino, Buenos Aires, B2700CPM, Argentina|GSK Investigational Site, Pilar, Buenos Aires, 1629, Argentina|GSK Investigational Site, Córdoba, Córdova, X5016KEH, Argentina|GSK Investigational Site, Buenos Aires, 1425, Argentina|GSK Investigational Site, Buenos Aires, C1181ACH, Argentina|GSK Investigational Site, Buenos Aires, CP1431FWO, Argentina|GSK Investigational Site, Formosa, P3600LLD, Argentina|GSK Investigational Site, Mendoza, M5500AFA, Argentina|GSK Investigational Site, Moron, B1708DPO, Argentina|GSK Investigational Site, San Miguel de Tucumán, T4000AHL, Argentina|GSK Investigational Site, Concord, New South Wales, 2139, Australia|GSK Investigational Site, Kingswood, New South Wales, 2750, Australia|GSK Investigational Site, Kogarah, New South Wales, 2217, Australia|GSK Investigational Site, Liverpool, New South Wales, 2170, Australia|GSK Investigational Site, St Leonards, New South Wales, 2065, Australia|GSK Investigational Site, Westmead, New South Wales, 2145, Australia|GSK Investigational Site, Wollongong, New South Wales, 2500, Australia|GSK Investigational Site, Birtinya, Queensland, 4575, Australia|GSK Investigational Site, Herston, Queensland, 4006, Australia|GSK Investigational Site, Woolloongabba, Queensland, 4102, Australia|GSK Investigational Site, Adelaide, South Australia, 5000, Australia|GSK Investigational Site, Clayton, Victoria, 3168, Australia|GSK Investigational Site, Melbourne, Victoria, 3004, Australia|GSK Investigational Site, St Albans, Victoria, 3021, Australia|GSK Investigational Site, Nedlands, Western Australia, 6009, Australia|GSK Investigational Site, Murdoch, 6150, Australia|GSK Investigational Site, Graz, 8036, Austria|GSK Investigational Site, St. Pölten, 3100, Austria|GSK Investigational Site, Wien, 1030, Austria|GSK Investigational Site, Wien, A-1130, Austria|GSK Investigational Site, Baudour, 7331, Belgium|GSK Investigational Site, Brugge, 8310, Belgium|GSK Investigational Site, Brussels, 1200, Belgium|GSK Investigational Site, Bruxelles, 1020, Belgium|GSK Investigational Site, Hasselt, 3500, Belgium|GSK Investigational Site, Ieper, 8900, Belgium|GSK Investigational Site, Leuven, 3000, Belgium|GSK Investigational Site, Liège, 4000, Belgium|GSK Investigational Site, Roeselare, 8800, Belgium|GSK Investigational Site, Salvador, Bahia, 40415-065, Brazil|GSK Investigational Site, Curitiba, Paraná, 80440-020, Brazil|GSK Investigational Site, Curitiba, Paraná, CEP 80230-130, Brazil|GSK Investigational Site, Passo Fundo, Rio Grande Do Sul, 99010-080, Brazil|GSK Investigational Site, Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil|GSK Investigational Site, Joinville, Santa Catarina, 89227-680, Brazil|GSK Investigational Site, Sao Jose do Rio Preto, São Paulo, 15090-000, Brazil|GSK Investigational Site, Belo Horizonte, Minas Gerais, 30150-221, Brazil|GSK Investigational Site, Feira de Santana, 44001-584, Brazil|GSK Investigational Site, Porto Alegre, 90035-070, Brazil|GSK Investigational Site, Porto Alegre, 90035-903, Brazil|GSK Investigational Site, Sao Paulo, 01323-001, Brazil|GSK Investigational Site, São Paulo, 01323903, Brazil|GSK Investigational Site, São Paulo, 04005-000, Brazil|GSK Investigational Site, São Paulo, 04039-000, Brazil|GSK Investigational Site, São Paulo, 08270-070, Brazil|GSK Investigational Site, Blagoevgrad, 2700, Bulgaria|GSK Investigational Site, Dobrich, 9300, Bulgaria|GSK Investigational Site, Gabrovo, 5300, Bulgaria|GSK Investigational Site, Lom, 3600, Bulgaria|GSK Investigational Site, Lovech, 5500, Bulgaria|GSK Investigational Site, Montana, 3400, Bulgaria|GSK Investigational Site, Pazardzhik, 4400, Bulgaria|GSK Investigational Site, Plovdiv, 4000, Bulgaria|GSK Investigational Site, Plovdiv, 4003, Bulgaria|GSK Investigational Site, Ruse, 7002, Bulgaria|GSK Investigational Site, Smolyan, 4700, Bulgaria|GSK Investigational Site, Sofia, 1233, Bulgaria|GSK Investigational Site, Sofia, 1309, Bulgaria|GSK Investigational Site, Sofia, 1709, Bulgaria|GSK Investigational Site, Varna, 9000, Bulgaria|GSK Investigational Site, Veliko Tarnovo, 5000, Bulgaria|GSK Investigational Site, Edmonton, Alberta, T6G 2B7, Canada|GSK Investigational Site, London, Ontario, N6A 5A5, Canada|GSK Investigational Site, Toronto, Ontario, M3M 0B2, Canada|GSK Investigational Site, Beroun, 26601, Czechia|GSK Investigational Site, Frýdek-mistek, 738 18, Czechia|GSK Investigational Site, Ivancice, 664 95, Czechia|GSK Investigational Site, Jilemnice, 514 01, Czechia|GSK Investigational Site, Marianske Lazne, 353 01, Czechia|GSK Investigational Site, Pardubice, 53203, Czechia|GSK Investigational Site, Praha 2, 128 08, Czechia|GSK Investigational Site, Praha 4, 14021, Czechia|GSK Investigational Site, Praha 4, 142 00, Czechia|GSK Investigational Site, Sokolov, 356 01, Czechia|GSK Investigational Site, Aalborg, DK-9000, Denmark|GSK Investigational Site, Holstebro, 7500, Denmark|GSK Investigational Site, Kolding, 6000, Denmark|GSK Investigational Site, Odense C, 5000, Denmark|GSK Investigational Site, Svendborg, 5700, Denmark|GSK Investigational Site, Parnu, 80011, Estonia|GSK Investigational Site, Tallinn, EE-13419, Estonia|GSK Investigational Site, Tartu, 50501, Estonia|GSK Investigational Site, Annonay, 07103, France|GSK Investigational Site, Bois-Guillaume, 76230, France|GSK Investigational Site, Bordeaux, 33076, France|GSK Investigational Site, Boulogne Billancourt, 92100, France|GSK Investigational Site, Caen Cedex 9, 14033, France|GSK Investigational Site, Mulhouse, 68100, France|GSK Investigational Site, Poitiers, 86021, France|GSK Investigational Site, Reims, 51092, France|GSK Investigational Site, Tours cedex 9, 37044, France|GSK Investigational Site, Mannheim, Baden-Wuerttemberg, 68167, Germany|GSK Investigational Site, Bad Koenig, Hessen, 64732, Germany|GSK Investigational Site, Wiesbaden, Hessen, 65191, Germany|GSK Investigational Site, Rostock, Mecklenburg-Vorpommern, 18059, Germany|GSK Investigational Site, Cloppenburg, Niedersachsen, 49661, Germany|GSK Investigational Site, Duesseldorf, Nordrhein-Westfalen, 40210, Germany|GSK Investigational Site, Kaiserslautern, Rheinland-Pfalz, 67655, Germany|GSK Investigational Site, Kiel, Schleswig-Holstein, 24105, Germany|GSK Investigational Site, Dieburg, 64807, Germany|GSK Investigational Site, Freiburg, 79110, Germany|GSK Investigational Site, Minden, 32429, Germany|GSK Investigational Site, Alexandroupolis, 68100, Greece|GSK Investigational Site, Arta, 471 00, Greece|GSK Investigational Site, Athens, 11527, Greece|GSK Investigational Site, Heraklion-Crete, 71110, Greece|GSK Investigational Site, Ioannina, 45001, Greece|GSK Investigational Site, Ioannina, 45500, Greece|GSK Investigational Site, Komotini, 69100, Greece|GSK Investigational Site, Larissa, 41110, Greece|GSK Investigational Site, Patras, 26500, Greece|GSK Investigational Site, Thessaloniki, 546 42, Greece|GSK Investigational Site, Thessaloniki, 54636, Greece|GSK Investigational Site, Thessaloniki, 56403, Greece|GSK Investigational Site, Thessaloniki, 57001, Greece|GSK Investigational Site, Budapest, 1077, Hungary|GSK Investigational Site, Egri, 3300, Hungary|GSK Investigational Site, Esztergom, 2500, Hungary|GSK Investigational Site, Kecskemet, 6001, Hungary|GSK Investigational Site, Miskolc, 3526, Hungary|GSK Investigational Site, Pécs, 7624, Hungary|GSK Investigational Site, Pécs, 7633, Hungary|GSK Investigational Site, Szigetvar, 7900, Hungary|GSK Investigational Site, Ahmedabad, 380059, India|GSK Investigational Site, Bangalore, 560054, India|GSK Investigational Site, Bangalore, 560055, India|GSK Investigational Site, Calicut, 673008, India|GSK Investigational Site, Chennai, Tamil Nadu, 600 006, India|GSK Investigational Site, Chennai, 600 034, India|GSK Investigational Site, Delhi, 110076, India|GSK Investigational Site, Gurgaon, 122001, India|GSK Investigational Site, Hyderabad, 500034, India|GSK Investigational Site, Jaipur, 302004, India|GSK Investigational Site, Mumbai, 400016, India|GSK Investigational Site, Nadiad, 387001, India|GSK Investigational Site, Nagpur, 440010, India|GSK Investigational Site, New Delhi, 110017, India|GSK Investigational Site, New Delhi, 110025, India|GSK Investigational Site, New Delhi, 110060, India|GSK Investigational Site, Pune, 411004, India|GSK Investigational Site, Pune, 411033, India|GSK Investigational Site, Secunderabad, 560020, India|GSK Investigational Site, Trivandrum, 695011, India|GSK Investigational Site, Catanzaro, Calabria, 88100, Italy|GSK Investigational Site, Reggio Calabria, Calabria, 89124, Italy|GSK Investigational Site, Napoli, Campania, 80131, Italy|GSK Investigational Site, Piacenza, Emilia-Romagna, 29100, Italy|GSK Investigational Site, Genova, Liguria, 16132, Italy|GSK Investigational Site, Bergamo, Lombardia, 24127, Italy|GSK Investigational Site, Lecco, Lombardia, 23900, Italy|GSK Investigational Site, Milano, Lombardia, 20153, Italy|GSK Investigational Site, Monza, Lombardia, 20900, Italy|GSK Investigational Site, Pavia, Lombardia, 27100, Italy|GSK Investigational Site, Seriate, Lombardia, 24068, Italy|GSK Investigational Site, Torino, Piemonte, 10154, Italy|GSK Investigational Site, Foggia, Puglia, 71100, Italy|GSK Investigational Site, Cagliari, Sardegna, 09100, Italy|GSK Investigational Site, Imola, 40026, Italy|GSK Investigational Site, Mestre, 30122, Italy|GSK Investigational Site, Anyang-Si, Gyeonggi-do, 14068, Korea, Republic of|GSK Investigational Site, Bucheon-si,, 14647, Korea, Republic of|GSK Investigational Site, Busan, 48108, Korea, Republic of|GSK Investigational Site, Daegu-si, 42601, Korea, Republic of|GSK Investigational Site, Daejeon, 35233, Korea, Republic of|GSK Investigational Site, Goyang-si, Gyeonggi-do, 411706, Korea, Republic of|GSK Investigational Site, Goyang-si, 10475, Korea, Republic of|GSK Investigational Site, Goyang-si, 410-719, Korea, Republic of|GSK Investigational Site, Gyeonggi-do, 463-707, Korea, Republic of|GSK Investigational Site, Incheon, 405-760, Korea, Republic of|GSK Investigational Site, Seoul, 05030, Korea, Republic of|GSK Investigational Site, Seoul, 05355, Korea, Republic of|GSK Investigational Site, Seoul, 07061, Korea, Republic of|GSK Investigational Site, Seoul, 07441, Korea, Republic of|GSK Investigational Site, Seoul, 134-727, Korea, Republic of|GSK Investigational Site, Seoul, 135-720, Korea, Republic of|GSK Investigational Site, Seoul, 150-713, Korea, Republic of|GSK Investigational Site, Seoul, 158-710, Korea, Republic of|GSK Investigational Site, Suwon, 442-723, Korea, Republic of|GSK Investigational Site, Uijeongbu-si, 11765, Korea, Republic of|GSK Investigational Site, Wonju-si, 26426, Korea, Republic of|GSK Investigational Site, Batu Caves, 68100, Malaysia|GSK Investigational Site, Ipoh, 30990, Malaysia|GSK Investigational Site, Johor Bahru, 80100, Malaysia|GSK Investigational Site, Kuala Lumpur, 50603, Malaysia|GSK Investigational Site, Pahang, 28000, Malaysia|GSK Investigational Site, Penang, 10990, Malaysia|GSK Investigational Site, Saltillo, Coahuila, CP 25230, Mexico|GSK Investigational Site, Durango., Durango, 34000, Mexico|GSK Investigational Site, Ciudad De México, Estado De México, 14000, Mexico|GSK Investigational Site, Cuautitlan Izcalli, Estado De México, 54769, Mexico|GSK Investigational Site, Guadalajara, Jalisco, 44620, Mexico|GSK Investigational Site, Guadalajara, Jalisco, 44650, Mexico|GSK Investigational Site, Queretaro, Querétaro, 76000, Mexico|GSK Investigational Site, Merida, Yucatán, 97070, Mexico|GSK Investigational Site, Aguascalientes, 20230, Mexico|GSK Investigational Site, Chihuahua, 31203, Mexico|GSK Investigational Site, Chihuahua, 31217, Mexico|GSK Investigational Site, México, D.F., 14080, Mexico|GSK Investigational Site, Zapopan, Jalisco, 45030, Mexico|GSK Investigational Site, Amsterdam, 1081 HV, Netherlands|GSK Investigational Site, Deventer, 7416 SE, Netherlands|GSK Investigational Site, Rotterdam, 3079 DZ, Netherlands|GSK Investigational Site, Hamilton, 2001, New Zealand|GSK Investigational Site, Hastings, 4156, New Zealand|GSK Investigational Site, Otahuhu, 1640, New Zealand|GSK Investigational Site, Oslo, 0405, Norway|GSK Investigational Site, Stavanger, 4011, Norway|GSK Investigational Site, Biala Podlaska, 21-500, Poland|GSK Investigational Site, Gdansk, 80-462, Poland|GSK Investigational Site, Grojec, 05-600, Poland|GSK Investigational Site, Kielce, 25-736, Poland|GSK Investigational Site, Kolobrzeg, 78-100, Poland|GSK Investigational Site, Kolo, 62-600, Poland|GSK Investigational Site, Lodz, 90-262, Poland|GSK Investigational Site, Lodz, 92-213, Poland|GSK Investigational Site, Olkusz, 32-300, Poland|GSK Investigational Site, Pruszkow, 05-800, Poland|GSK Investigational Site, Tomaszow Mazowiecki, 97-200, Poland|GSK Investigational Site, Warszawa, 02-758, Poland|GSK Investigational Site, Zary, 68-200, Poland|GSK Investigational Site, Amadora, 2700-391, Portugal|GSK Investigational Site, Corroios., 2855227, Portugal|GSK Investigational Site, Covilhã, 6200-000, Portugal|GSK Investigational Site, Forte Da Casa, 2625-437, Portugal|GSK Investigational Site, Lisboa, 1069-166, Portugal|GSK Investigational Site, Lisboa, 1250-203, Portugal|GSK Investigational Site, Lisboa, 1400-195, Portugal|GSK Investigational Site, Lisboa, 1750-130, Portugal|GSK Investigational Site, Mirandela, 5370-530, Portugal|GSK Investigational Site, Portimão, 8500-311, Portugal|GSK Investigational Site, Vila Franca de Xira, 2600-076, Portugal|GSK Investigational Site, Vila Real (Lordelo), 5000-668, Portugal|GSK Investigational Site, Arad, 310141, Romania|GSK Investigational Site, Bucharest, 022328, Romania|GSK Investigational Site, Resita, 320166, Romania|GSK Investigational Site, Targu-Jiu, 210146, Romania|GSK Investigational Site, Irkutsk, 664049, Russian Federation|GSK Investigational Site, Krasnodar, 350029, Russian Federation|GSK Investigational Site, Mytischi, 141009, Russian Federation|GSK Investigational Site, Nizhniy Novgorod, 603126, Russian Federation|GSK Investigational Site, Novosibirsk, 630087, Russian Federation|GSK Investigational Site, Omsk, 644112, Russian Federation|GSK Investigational Site, Orenburg, 460040, Russian Federation|GSK Investigational Site, Penza, 440034, Russian Federation|GSK Investigational Site, St-Petersburg, 197110, Russian Federation|GSK Investigational Site, St. Petersburg, 191104, Russian Federation|GSK Investigational Site, St. Petersburg, 194354, Russian Federation|GSK Investigational Site, St. Petersburg, 196247, Russian Federation|GSK Investigational Site, Volzhsky, 404120, Russian Federation|GSK Investigational Site, Yaroslavl, 150062, Russian Federation|GSK Investigational Site, Singapore, 119074, Singapore|GSK Investigational Site, Singapore, 169608, Singapore|GSK Investigational Site, Singapore, 308433, Singapore|GSK Investigational Site, Cape Town., 7925, South Africa|GSK Investigational Site, Cape Town, 7500, South Africa|GSK Investigational Site, Majadahonda, Madrid, 28222, Spain|GSK Investigational Site, Alcala de Henares, 28805, Spain|GSK Investigational Site, Aranda de Duero, 09400, Spain|GSK Investigational Site, Badalona, 08036, Spain|GSK Investigational Site, Badalona, 08916, Spain|GSK Investigational Site, Barcelona, 08003, Spain|GSK Investigational Site, Barcelona, 08025, Spain|GSK Investigational Site, Ciudad Real, 13005, Spain|GSK Investigational Site, Girona, 17007, Spain|GSK Investigational Site, Guadalajara, 19002, Spain|GSK Investigational Site, Madrid, 28007, Spain|GSK Investigational Site, Madrid, 28020, Spain|GSK Investigational Site, Madrid, 28040, Spain|GSK Investigational Site, Manises (Valencia), 46940, Spain|GSK Investigational Site, Mollet del Valles, 08100, Spain|GSK Investigational Site, Málaga, 29530, Spain|GSK Investigational Site, Palma de Mallorca, 07120, Spain|GSK Investigational Site, Sabadell, 08208, Spain|GSK Investigational Site, Santiago de Compostela, 15706, Spain|GSK Investigational Site, Sevilla, 41071, Spain|GSK Investigational Site, Valladolid, 47005, Spain|GSK Investigational Site, Stockholm, SE-141 86, Sweden|GSK Investigational Site, Stockholm, SE-182 88, Sweden|GSK Investigational Site, Uppsala, 756 55, Sweden|GSK Investigational Site, Örebro, SE-701 85, Sweden|GSK Investigational Site, Kaohsiung, 807, Taiwan|GSK Investigational Site, Kaohsiung, 83301, Taiwan|GSK Investigational Site, Keelung, 204, Taiwan|GSK Investigational Site, New Taipei City, 23561, Taiwan|GSK Investigational Site, New Taipei City, 237, Taiwan|GSK Investigational Site, New Taipei, 220, Taiwan|GSK Investigational Site, Tainan, 704, Taiwan|GSK Investigational Site, Taipei, 112, Taiwan|GSK Investigational Site, Taipei, 116, Taiwan|GSK Investigational Site, Taoyuan Hsien, 333, Taiwan|GSK Investigational Site, Zhongzheng Dist., Taipei, 10002, Taiwan|GSK Investigational Site, Adana, 01330, Turkey|GSK Investigational Site, Ankara, 06100, Turkey|GSK Investigational Site, Antalya, 07059, Turkey|GSK Investigational Site, Edirne, 22030, Turkey|GSK Investigational Site, Eskisehir, 26480, Turkey|GSK Investigational Site, Kayseri, 38039, Turkey|GSK Investigational Site, Chernihiv, 14029, Ukraine|GSK Investigational Site, Chernivtsi, 58005, Ukraine|GSK Investigational Site, Ivano-Frankivsk, 76008, Ukraine|GSK Investigational Site, Kherson, 73039, Ukraine|GSK Investigational Site, Kiev, 04107, Ukraine|GSK Investigational Site, Kyiv, 01023, Ukraine|GSK Investigational Site, Kyiv, 04050, Ukraine|GSK Investigational Site, Kyiv, 04112, Ukraine|GSK Investigational Site, Mykolaiv, 54058, Ukraine|GSK Investigational Site, Ternopil, 46002, Ukraine|GSK Investigational Site, Zaporizhzhia, 69001, Ukraine|GSK Investigational Site, Zaporizhzhia, 69600, Ukraine|GSK Investigational Site, Zhytomyr, 10002, Ukraine|GSK Investigational Site, Stevenage, Hertfordshire, SG1 4AB, United Kingdom|GSK Investigational Site, Preston, Lancashire, PR2 9HT, United Kingdom|GSK Investigational Site, Wolverhampton, West Midlands, WV10 0QP, United Kingdom|GSK Investigational Site, Birmingham, B9 5SS, United Kingdom|GSK Investigational Site, Derby, DE22 3NE, United Kingdom|GSK Investigational Site, Doncaster, DN2 5LT, United Kingdom|GSK Investigational Site, Dundee, DD1 9SY, United Kingdom|GSK Investigational Site, Fife, KY2 5AH, United Kingdom|GSK Investigational Site, Glasgow, G51 4TF, United Kingdom|GSK Investigational Site, Hull, HU3 2JZ, United Kingdom|GSK Investigational Site, London, E1 1BB, United Kingdom|GSK Investigational Site, London, SE5 9RS, United Kingdom|GSK Investigational Site, Oxford, OX3 7LE, United Kingdom|GSK Investigational Site, Salford, M6 8HD, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT02879305 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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