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Clinical Trial Details

Trial ID: L0411
Source ID: NCT01356849
Associated Drug: Atrasentan
Title: Evaluate the Efficacy and Safety of Once Daily Administration of Atrasentan Tablets (Low and High) Compared to Placebo in Reducing Residual Albuminuria in Type 2 Diabetic Patients With Nephropathy Who Are Treated With the Maximum Tolerated Labeled Dose of a Renin Angiotensin System (RAS) Inhibitor
Acronym: RADAR
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|Diabetic Nephropathy
Interventions: DRUG: Atrasentan|DRUG: Placebo
Outcome Measures: Primary: Change from baseline to Week 12 in Urinary Albumin to Creatinine Ratio (UACR), Every two weeks for 12 weeks | Secondary: Differences in change from baseline to each post baseline measure for estimated glomerular filtration rate (eGFR), Every two weeks for 12 weeks|Differences in change from baseline to each post baseline measure for EQ-5D Index Score, Once a month for 3 months|Differences in change from baseline to each post baseline measure for each of the Kidney Disease Quality of Life (KDQOL) Kidney Disease Targeted Scales, Once a month for 3 months
Sponsor/Collaborators: Sponsor: AbbVie (prior sponsor, Abbott)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 149
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-04
Completion Date: 2012-08
Results First Posted:
Last Update Posted: 2013-08-28
Locations: Site Reference ID/Investigator# 46345, Pell City, Alabama, 35128, United States|Site Reference ID/Investigator# 46035, Tempe, Arizona, 85284, United States|Site Reference ID/Investigator# 46016, Azusa, California, 91702, United States|Site Reference ID/Investigator# 45992, Chula Vista, California, 91910, United States|Site Reference ID/Investigator# 46000, La Mesa, California, 91942, United States|Site Reference ID/Investigator# 46038, Lincoln, California, 95648, United States|Site Reference ID/Investigator# 45994, Long Beach, California, 90806, United States|Site Reference ID/Investigator# 45998, Los Angeles, California, 90022, United States|Site Reference ID/Investigator# 47584, Los Gatos, California, 95032, United States|Site Reference ID/Investigator# 64465, National City, California, 91950, United States|Site Reference ID/Investigator# 65862, Orange, California, 92868, United States|Site Reference ID/Investigator# 46019, Riverside, California, 92505, United States|Site Reference ID/Investigator# 46110, Salinas, California, 93901, United States|Site Reference ID/Investigator# 46017, Yuba City, California, 95991, United States|Site Reference ID/Investigator# 46662, Westminster, Colorado, 80031, United States|Site Reference ID/Investigator# 46033, Coral Gables, Florida, 33134, United States|Site Reference ID/Investigator# 45989, Hialeah, Florida, 33012, United States|Site Reference ID/Investigator# 46667, Lauderdale Lakes, Florida, 33313, United States|Site Reference ID/Investigator# 46123, Miami, Florida, 33135, United States|Site Reference ID/Investigator# 46115, Ocala, Florida, 34471, United States|Site Reference ID/Investigator# 46664, Pembroke Pines, Florida, 33027, United States|Site Reference ID/Investigator# 46031, Pembroke Pines, Florida, 33028, United States|Site Reference ID/Investigator# 46040, Pembroke Pines, Florida, 33028, United States|Site Reference ID/Investigator# 46122, Port Charlotte, Florida, 33952, United States|Site Reference ID/Investigator# 46015, West Palm Beach, Florida, 33401, United States|Site Reference ID/Investigator# 50482, Jonesboro, Georgia, 30236, United States|Site Reference ID/Investigator# 46034, Meridian, Idaho, 83642, United States|Site Reference ID/Investigator# 46666, Chicago, Illinois, 60616, United States|Site Reference ID/Investigator# 45996, Evergreen Park, Illinois, 60805, United States|Site Reference ID/Investigator# 46002, Gurnee, Illinois, 60031, United States|Site Reference ID/Investigator# 46111, Shreveport, Louisiana, 71101, United States|Site Reference ID/Investigator# 46030, Oxon Hill, Maryland, 20745, United States|Site Reference ID/Investigator# 45991, Rockville, Maryland, 20852, United States|Site Reference ID/Investigator# 46025, Novi, Michigan, 48374, United States|Site Reference ID/Investigator# 46023, Brooklyn Center, Minnesota, 55430, United States|Site Reference ID/Investigator# 46062, Farmington, Missouri, 63640, United States|Site Reference ID/Investigator# 48942, Omaha, Nebraska, 68131-3403, United States|Site Reference ID/Investigator# 46349, Omaha, Nebraska, 68131, United States|Site Reference ID/Investigator# 46116, Las Vegas, Nevada, 89106, United States|Site Reference ID/Investigator# 50483, Albany, New York, 12206, United States|Site Reference ID/Investigator# 68328, New Hyde Park, New York, 11042, United States|Site Reference ID/Investigator# 65863, Asheville, North Carolina, 28801, United States|Site Reference ID/Investigator# 50529, Greensboro, North Carolina, 27408, United States|Site Reference ID/Investigator# 46129, Greenville, North Carolina, 27834, United States|Site Reference ID/Investigator# 46022, Morehead City, North Carolina, 28557, United States|Site Reference ID/Investigator# 46224, Doylestown, Pennsylvania, 18901, United States|Site Reference ID/Investigator# 46028, Orangeburg, South Carolina, 29118, United States|Site Reference ID/Investigator# 46702, Orangeburg, South Carolina, 29118, United States|Site Reference ID/Investigator# 46024, Greenville, Texas, 75402, United States|Site Reference ID/Investigator# 46228, Houston, Texas, 77004, United States|Site Reference ID/Investigator# 47068, Houston, Texas, 77004, United States|Site Reference ID/Investigator# 64464, Houston, Texas, 77054, United States|Site Reference ID/Investigator# 64483, Mission, Texas, 78572, United States|Site Reference ID/Investigator# 46348, San Antonio, Texas, 78215, United States|Site Reference ID/Investigator# 46063, San Antonio, Texas, 78229-4801, United States|Site Reference ID/Investigator# 68486, San Antonio, Texas, 78229, United States|Site Reference ID/Investigator# 46669, Bennington, Vermont, 05201, United States|Site Reference ID/Investigator# 46026, Alexandria, Virginia, 22304, United States|Site Reference ID/Investigator# 46027, Fairfax, Virginia, 22030, United States|Site Reference ID/Investigator# 67762, Kitchener, N2H 5Z8, Canada|Site Reference ID/Investigator# 50526, Sarnia, N7T 4X3, Canada|Site Reference ID/Investigator# 50525, Thornhill, L4J 8L7, Canada|Site Reference ID/Investigator# 47067, Caguas, 00725, Puerto Rico|Site Reference ID/Investigator# 50522, Manati, 00674, Puerto Rico|Site Reference ID/Investigator# 46352, Ponce, 00717-1322, Puerto Rico|Site Reference ID/Investigator# 46351, Ponce, 00717-2075, Puerto Rico|Site Reference ID/Investigator# 46133, Ponce, 00717, Puerto Rico|Site Reference ID/Investigator# 46131, Rio Piedras, 00935, Puerto Rico|Site Reference ID/Investigator# 46132, San Juan, 00918, Puerto Rico|Site Reference ID/Investigator# 46230, Santurce, 00909-2244, Puerto Rico|Site Reference ID/Investigator# 51566, Taichung City, 40447, Taiwan|Site Reference ID/Investigator# 51567, Taichung, 40705, Taiwan
URL: https://clinicaltrials.gov/show/NCT01356849

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D440 Atrasentan small molecule DB06199 Details