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Clinical Trial Details

Trial ID: L7038
Source ID: NCT00654745
Associated Drug: Amlodipine
Title: 18 Week Study Evaluating Safety and Efficacy of Olmesartan, Amlodipine, and Hydrochlorothiazide, in Type 2 Diabetics
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00654745/results
Conditions: Type 2 Diabetes|Hypertension
Interventions: DRUG: Amlodipine|DRUG: amlodipine / olmesartan medoxomil combination|DRUG: Hydrochlorothiazide
Outcome Measures: Primary: Change From Week 0 (Baseline) in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) After 12 Weeks of Active Treatment, Change from week 0 (baseline) in mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (SBP) after 12 weeks of active treatment. change = week 12 - week 0., week 0 - week 12 | Secondary: Change From Week 0 (Baseline) in Mean ABPM Diastolic Blood Pressure (DBP) After 12 Weeks of Active Treatment, 24-hour mean DBP, Daytime mean DBP, Nighttime mean DBP, Last 6 hour mean DBP, Last 4 hour mean DBP, Last 2 hour mean DBP, week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)|Change From Week 0 (Baseline) in Mean ABPM SBP After 12 Weeks of Active Treatment, Daytime mean SBP, Nighttime mean SBP, Last 6 hour mean SBP, Last 4 hour mean SBP, Last 2 hour mean SBP, week 0 - week 12 (24-hour, Daytime, Nighttime, Last 6 hour, Last 4 hour, Last 2 hour)|Change in Mean Seated Systolic Blood Pressure (SeSBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks, change in mean SeSBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18., week 0 - weeks 3, 6, 9, 12, 15, 18|Change in Mean Seated Diastolic Blood Pressure (SeDBP) From Week 0 (Baseline) After 3, 6, 9, 12, 15, and 18 Weeks, change in mean SeDBP from week 0 (baseline) to Weeks 3, 6, 9, 12, 15, and 18., week 0 - weeks 3, 6, 9, 12, 15, 18|Number of Participants Achieving Mean 24-hour Ambulatory Blood Pressure Thresholds at Week 12, number of participants achieving mean 24-hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12, week 0 - week 12|Number of Participants Achieving Mean Daytime Ambulatory Blood Pressure Thresholds at Week 12, number of participants achieving mean daytime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12, week 0 - week 12|Number of Participants Achieving Mean Nighttime Ambulatory Blood Pressure Thresholds at Week 12, number of participants achieving mean nighttime ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, BP\<120/70, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75, DBP\<70 at week 12, week 0 - week 12|Number of Participants Achieving Mean Last 6 Hour Ambulatory Blood Pressure Thresholds at Week 12, number participants achieving mean last 6 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12, week 0 - week 12|Number of Participants Achieving Mean Last 4 Hour Ambulatory Blood Pressure Thresholds at Week 12, number of participants achieving mean last 4 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12, week 0 - week 12|Number of Participants Achieving Mean Last 2 Hour Ambulatory Blood Pressure Thresholds at Week 12, number of participants achieving mean last 2 hour ambulatory blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12, week 0 - week 12|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 3, number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 3, week 0 - week 3|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 6, number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 6, week 0 - week 6|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 9, number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 9, week 0 - week 9|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 12, number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 12, week 0 - week 12|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 15, number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 15, week 0 - week 15|Number of Participants Achieving Seated Systolic and Diastolic Blood Pressure Thresholds at Week 18, number of participants achieving seated systolic and diastolic blood pressure thresholds BP\<135/85, BP\<130/80, BP\<125/75, BP\<120/80, SBP\<135, SBP\<130, SBP\<125, SBP\<120, DBP\<85, DBP\<80, DBP\<75 at week 18, week 0 - week 18|Number of Participants Achieving Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12, number of participants achieving mean 24 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Daytime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12, number of participants achieving mean daytime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Nighttime Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12, number of participants achieving mean nighttime ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Last 6 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12, number of participants achieving mean last 6 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Last 4 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions, number of participants achieving mean last 4 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Last 2 Hour Ambulatory Systolic and Diastolic Blood Pressure Reductions at Week 12, number of participants achieving mean last 2 hour ambulatory systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 3, number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 3, week 0 - week 3|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 6, number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 6, week 0 - week 6|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 9, number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 9, week 0 - week 9|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 12, number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 12, week 0 - week 12|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 15, number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 15, week 0 - week 15|Number of Participants Achieving Mean Seated Systolic and Diastolic Blood Pressure Reductions at Week 18, number of participants achieving mean seated systolic and diastolic blood pressure reductions of; SBP reduction \<= 15 mmHg, SBP reduction \> 15 mmHg \& \<= 30 mmHg, SBP reduction \> 30 mmHg \& \<= 45 mmHg, SBP reduction \> 45 mmHg, DBP reduction \<= 10 mmHg, DBP reduction \> 10 mmHg \& \<= 15 mmHg, DBP reduction \> 15 mmHg \& \<= 20 mmHg, DBP reduction \> 20 mmHg at week 18, week 0 - week 18
Sponsor/Collaborators: Sponsor: Daiichi Sankyo
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 207
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-05
Completion Date: 2009-06
Results First Posted: 2010-07-02
Last Update Posted: 2010-07-13
Locations: Los Angeles, California, United States|Sylmar, California, United States|Tustin, California, United States|Aventura, Florida, United States|DeLand, Florida, United States|Hialeah, Florida, United States|Pembroke Pines, Florida, United States|Avon, Indiana, United States|Indianapolis, Indiana, United States|Las Vegas, Nevada, United States|New Windsor, New York, United States|Winston-Salem, North Carolina, United States|Cincinnati, Ohio, United States|Oklahoma City, Oklahoma, United States|Charleston, South Carolina, United States|Greer, South Carolina, United States|Taylors, South Carolina, United States|Nashville, Tennessee, United States|Dallas, Texas, United States|San Antonio, Texas, United States|Burke, Virginia, United States
URL: https://clinicaltrials.gov/show/NCT00654745

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D104 Amlodipine small molecule DB00381 Details
D296 Hydrochlorothiazide small molecule DB00999 Details