Status:
COMPLETED
A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
Lead Sponsor:
Esperion Therapeutics, Inc.
Conditions:
Hyperlipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with...
Eligibility Criteria
Inclusion
- Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
- Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
- Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening
Exclusion
- Total Fasting Triglyceride ≥ 400 mg/dL
- Renal Dysfunction or nephrotic syndrome or history of nephritis
- Significant cardiovascular disease or cardiovascular event within the past 3 months
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2018
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT03337308
Start Date
October 23 2017
End Date
July 18 2018
Last Update
April 8 2020
Active Locations (5)
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1
PMG Research of McFarland
Ames, Iowa, United States, 50010
2
Foundation Cardiology
Nashua, New Hampshire, United States, 03060
3
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States, 28625
4
PMG Research of Wilmington
Wilmington, North Carolina, United States, 28401