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Clinical Trial Details

Trial ID: L1159
Source ID: NCT00977080
Associated Drug: Paricalcitol
Title: Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D
Acronym: IMPACT SHPT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00977080/results
Conditions: Chronic Kidney Disease|Secondary Hyperparathyroidism|Hemodialysis
Interventions: DRUG: Paricalcitol|DRUG: Cinacalcet
Outcome Measures: Primary: The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28)., iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted., Weeks 21 to 28 | Secondary: Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28)., iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted., Weeks 21 to 28|Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28)., iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted., Weeks 21 to 28|Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata, iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together., Weeks 21 to 28|Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28), Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was \< 8.4 mg/dL were counted., Weeks 21 to 28|Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28), Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was \> 10.5 mg/dL were counted., Weeks 21 to 28
Sponsor/Collaborators: Sponsor: Abbott
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 272
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2009-11
Completion Date: 2011-05
Results First Posted: 2012-06-20
Last Update Posted: 2012-06-20
Locations: Site Reference ID/Investigator# 22781, Tempe, Arizona, 85284, United States|Site Reference ID/Investigator# 24342, Chula Vista, California, 91910, United States|Site Reference ID/Investigator# 21142, Los Angeles, California, 90033, United States|Site Reference ID/Investigator# 22762, Los Angeles, California, 90048, United States|Site Reference ID/Investigator# 22758, Riverside, California, 92505, United States|Site Reference ID/Investigator# 21442, San Diego, California, 92123, United States|Site Reference ID/Investigator# 23688, Arvada, Colorado, 80002, United States|Site Reference ID/Investigator# 21370, Coral Springs, Florida, 33071, United States|Site Reference ID/Investigator# 25902, Hudson, Florida, 34667, United States|Site Reference ID/Investigator# 21146, Lauderdale Lakes, Florida, 33313, United States|Site Reference ID/Investigator# 26743, Lauderdale Lakes, Florida, 33313, United States|Site Reference ID/Investigator# 22788, Miami, Florida, 33173, United States|Site Reference ID/Investigator# 22722, Orlando, Florida, 32806, United States|Site Reference ID/Investigator# 23147, Tampa, Florida, 33614, United States|Site Reference ID/Investigator# 22778, Meridian, Idaho, 83642, United States|Site Reference ID/Investigator# 21369, Detroit, Michigan, 48202, United States|Site Reference ID/Investigator# 22786, Detroit, Michigan, 48236, United States|Site Reference ID/Investigator# 21144, St. Louis, Missouri, 63110, United States|Site Reference ID/Investigator# 21443, St. Louis, Missouri, 63110, United States|Site Reference ID/Investigator# 21145, Omaha, Nebraska, 68131, United States|Site Reference ID/Investigator# 22505, Flushing, New York, 11355, United States|Site Reference ID/Investigator# 22759, Toledo, Ohio, 43606, United States|Site Reference ID/Investigator# 22796, Lancaster, Pennsylvania, 17604, United States|Site Reference ID/Investigator# 22770, Philadelphia, Pennsylvania, 19106, United States|Site Reference ID/Investigator# 22772, Aiken, South Carolina, 29801, United States|Site Reference ID/Investigator# 21147, Orangeburg, South Carolina, 29115, United States|Site Reference ID/Investigator# 22982, Houston, Texas, 77030, United States|Site Reference ID/Investigator# 21143, Houston, Texas, 77099, United States|Site Reference ID/Investigator# 22506, San Antonio, Texas, 78215, United States|Site Reference ID/Investigator# 22776, Bluefield, West Virginia, 24701, United States|Site Reference ID/Investigator# 22311, Brno, 65691, Czech Republic|Site Reference ID/Investigator# 22310, Jilemnice, 51415, Czech Republic|Site Reference ID/Investigator# 21624, Usti nad Labem, 40113, Czech Republic|Site Reference ID/Investigator# 22363, Aalborg, 9000, Denmark|Site Reference ID/Investigator# 23105, Copenhagen, 2100, Denmark|Site Reference ID/Investigator# 23909, Fredericia, 7000, Denmark|Site Reference ID/Investigator# 22462, Holstebro, 7500, Denmark|Site Reference ID/Investigator# 21748, Coburg, 96450, Germany|Site Reference ID/Investigator# 33268, Darmstadt, 64295, Germany|Site Reference ID/Investigator# 35903, Duesseldorf, 40210, Germany|Site Reference ID/Investigator# 21742, Frankfurt, 60590, Germany|Site Reference ID/Investigator# 21744, Heilbronn, 74076, Germany|Site Reference ID/Investigator# 21368, Luedenscheid, 58515, Germany|Site Reference ID/Investigator# 22362, Athens, 11528, Greece|Site Reference ID/Investigator# 38970, Thessaloniki, 546 36, Greece|Site Reference ID/Investigator# 22322, Thessaloniki, 54636, Greece|Site Reference ID/Investigator# 22463, Thessaloniki, 54642, Greece|Site Reference ID/Investigator# 22323, Thessaloniki, 56403, Greece|Site Reference ID/Investigator# 39262, Thessaloniki, 570 01, Greece|Site Reference ID/Investigator# 22312, Bergamo, 24128, Italy|Site Reference ID/Investigator# 21746, Genova, 16132, Italy|Site Reference ID/Investigator# 39180, Lucca, 55100, Italy|Site Reference ID/Investigator# 22314, Milan, 20122, Italy|Site Reference ID/Investigator# 21367, Pavia, 27100, Italy|Site Reference ID/Investigator# 21745, Pesaro, 61100, Italy|Site Reference ID/Investigator# 21842, Alkmaar, 1815 JD, Netherlands|Site Reference ID/Investigator# 22309, Delft, 2625 AD, Netherlands|Site Reference ID/Investigator# 21843, Dordrecht, 3317 NM, Netherlands|Site Reference ID/Investigator# 38903, Beja, 7800-309, Portugal|Site Reference ID/Investigator# 38531, Faro, 8005- 546, Portugal|Site Reference ID/Investigator# 22464, Lisbon, 1750-130, Portugal|Site Reference ID/Investigator# 23910, Vila Franca de Xira, 2600-076, Portugal|Site Reference ID/Investigator# 24643, Moscow, 123182, Russian Federation|Site Reference ID/Investigator# 24642, Moscow, 125284, Russian Federation|Site Reference ID/Investigator# 21361, Barcelona, 08025, Spain|Site Reference ID/Investigator# 21364, Cordoba, 14004, Spain|Site Reference ID/Investigator# 22366, L'Hospitalet, Barcelona, 08097, Spain|Site Reference ID/Investigator# 38343, Madrid, 28040, Spain|Site Reference ID/Investigator# 21362, Madrid, 28041, Spain|Site Reference ID/Investigator# 21363, Palma de Mallorca, 07014, Spain|Site Reference ID/Investigator# 22367, Pamplona, 31008, Spain|Site Reference ID/Investigator# 38462, Puerto de la Cruz, 38400, Spain|Site Reference ID/Investigator# 21365, Seville, 41007, Spain|Site Reference ID/Investigator# 23913, Linkoping, 58185, Sweden|Site Reference ID/Investigator# 23782, Stockholm, 182 88, Sweden|Site Reference ID/Investigator# 22364, Uppsala, 751 85, Sweden|Site Reference ID/Investigator# 23912, Birmingham, B18 7QH, United Kingdom|Site Reference ID/Investigator# 21747, Coventry, CV2 2DX, United Kingdom|Site Reference ID/Investigator# 23102, London, NW3 2PF, United Kingdom|Site Reference ID/Investigator# 23104, London, SE1 9RT, United Kingdom|Site Reference ID/Investigator# 23103, Manchester, M6 8HD, United Kingdom|Site Reference ID/Investigator# 41982, Omagh, Northern Ireland, BT79 0AP, United Kingdom|Site Reference ID/Investigator# 40222, Sheffield, S5 7AU, United Kingdom
URL: https://clinicaltrials.gov/show/NCT00977080

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D302 Cinacalcet small molecule DB01012 Details