Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk

Last updated: April 24, 2020
Sponsor: Esperion Therapeutics
Overall Status: Completed

Phase

3

Condition

Hypercholesterolemia

Vascular Diseases

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT02991118
1002-047
2016-003486-26
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Fasting LDL-C ≥100 mg/dL

  • High cardiovascular risk (diagnosis of HeFH and/or ASCVD)

  • Be on maximally tolerated lipid-modifying therapy (LMT), including maximally toleratedstatin either alone or in combination with other LMTs

Exclusion

Exclusion Criteria:

  • Total fasting triglyceride ≥500 mg/dL

  • Renal dysfunction or nephrotic syndrome or history of nephritis

  • Body Mass Index (BMI) ≥50kg/m2

  • Significant cardiovascular disease or cardiovascular event in the past 3 months

Study Design

Total Participants: 779
Study Start date:
November 18, 2016
Estimated Completion Date:
August 22, 2018

Connect with a study center

  • Clearwater, Florida
    United States

    Site Not Available

  • Georgetown, Texas
    United States

    Site Not Available

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