Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Arm, 12-week Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium 1, 2 and 4 mg in Patients With Fasting Triglyceride ≥500 mg/dL and ≤1500 mg/dL
Status: Suspended
Location: See all (33) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
To evaluate the safety and efficacy of Saroglitazar Magnesium 1, 2, and 4 mg in patients with fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults subjects (≥18 year) of either gender.
• Average fasting TG-C ≥500 mg/dL and ≤1500 mg/dL (from Visits 2 and 2.1).
• Able and willing to give written informed consent and comply with the requirements of the study protocol.
Locations
United States
Alabama
Medical Affiliated Research Center, Inc.
Huntsville
California
Encompass Clinical Research
Encinitas
Integrated Research Center
San Diego
Ventura Clinical Trials
Ventura
Colorado
Colorado Springs Health Partners
Colorado Springs
Florida
Meridien Research - Bradenton
Bradenton
Meridien Research - Lakeland
Lakeland
Oviedo Medical Research, LLC
Oviedo
Meridien Research - Tampa
Tampa
Georgia
River Birch Research Alliance LLC
Blue Ridge
Drug Studies America
Marietta
Herman Clinical Research, LLC
Suwanee
Illinois
Cedar-Crosse Research Center
Chicago
Kansas
Heartland Research Associates, LLC
Newton
Heartland Research Associates, LLC
Wichita
Maryland
University of Maryland Medical Center
Baltimore
Centennial Medical Group
Elkridge
MD Medical Research
Oxon Hill
Montana
Mercury Street Medical
Butte
North Carolina
Einstein Clinical Research
Charlotte
Triad Clinical Trials LLC
Greensboro
PMG Research of Wilmington, LLC
Wilmington
Ohio
Metabolic and Atherosclerosis Research Center
Cincinnati
Sterling Research Group, Ltd.
Cincinnati
Wells Institute for Health Awareness
Kettering
Ohio Clinical Research - Lyndhurst
Lyndhurst
Awasty Research Network, LLC
Marion
Ohio Clinical Research, LLC - Willoughby Hills
Willoughby Hills
Oregon
Columbia Research Group, Inc.
Portland
Tennessee
PMG Research of Bristol, LLC
Bristol
Jackson Clinic
Jackson
Texas
Pioneer Research Solutions Inc.
Houston
Virginia
National Clinical Research - Richmond, Inc
Richmond
Time Frame
Start Date: 2017-04-06
Completion Date: 2024-01
Participants
Target number of participants: 124
Treatments
Experimental: Saroglitazar magnesium 1 mg
Saroglitazar magnesium 1 mg tablet orally once a day for 12 weeks
Experimental: Saroglitazar magnesium 2 mg
Saroglitazar magnesium 2 mg tablet orally once a day for 12 weeks
Experimental: Saroglitazar magnesium 4 mg
Saroglitazar magnesium 4 mg tablet orally once a day for 12 weeks
Placebo_comparator: Placebo
Placebo tablet orally once a day for 12 weeks
Authors
Richard Glover, Padma Mangu, Howard Weintraub, Raymond Tidman, Alon Steinberg, Richard Montgomery, Vivek Awasty, Traci Turner, Cynthia Huffman, Kari Uusinarkaus, Michael Azorr, John Bertsch, Terence Isakov, Frederick A Martin, Brian R Webster, Robert Lipetz, Lee Herman, Tana Goering, Letitia Thompson-Hargrave, John Pullman, Bradley Block, Danny Sugimoto
Sponsors
Leads: Zydus Therapeutics Inc.