Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

Last updated: February 3, 2021
Sponsor: Esperion Therapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Vascular Diseases

Atherosclerosis

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT03067441
1002-050
2016-004115-12
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Successfully completed CLEAR Harmony (1002-040) parent study

Exclusion

Exclusion Criteria:

  • Experienced a treatment-related SAE that led to study drug discontinuation in theCLEAR Harmony (1002-040) parent study.
  • Medical condition requires lipid measurement and/or adjustment of backgroundlipid-regulating therapy.

Study Design

Total Participants: 1462
Study Start date:
February 03, 2017
Estimated Completion Date:
November 05, 2019

Connect with a study center

  • Jedidiah Clinical Research

    Tampa, Florida 33607
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Sentral Clinical Research Services

    Cincinnati, Ohio 45236
    United States

    Site Not Available

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