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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemias

In brief

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 elevated LDL cholesterol treated with maximally tolerated statin therapy.

Key facts

Study ID

NCT03337308

Run by

Esperion Therapeutics, Inc.

People needed

382

Starts

2017-10-23

Expected to finish

2018-07-18

Last updated by the study team

2020-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PMG Research of McFarland — Ames, Iowa, United States
• Foundation Cardiology — Nashua, New Hampshire, United States
• PMG Research of Piedmont Healthcare — Statesville, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• PMG Research of Knoxville — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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