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Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)

NCT02666664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2230

Last updated 2020-05-11

Study results available
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Summary

The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Conditions

Interventions

DRUG

ETC-1002

ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)

DRUG

Placebo

Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)

Sponsors & Collaborators

  • Esperion Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ron Haberman, MD · Esperion Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-21
Primary Completion
2018-02-21
Completion
2018-03-28

Countries

  • United States
  • Canada
  • Germany
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02666664 on ClinicalTrials.gov