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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

NCT03337308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2020-04-08

Study results available
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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 elevated LDL cholesterol treated with maximally tolerated statin therapy.

Conditions

  • Hyperlipidemias

Interventions

COMBINATION_PRODUCT

Bempedoic Acid + Ezetimibe Fixed-Dose Combination

bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet

DRUG

Bempedoic Acid

bempedoic acid 180 mg tablet

DRUG

Ezetimibe

ezetimibe 10 mg overencapsulated tablet

DRUG

Placebos

placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule

Sponsors & Collaborators

  • Esperion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Haberman, MD · Esperion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2018-06-18
Completion
2018-07-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337308 on ClinicalTrials.gov