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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Atherosclerotic Cardiovascular Diseases

In brief

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.

Key facts

Study ID

NCT02666664

Run by

Esperion Therapeutics, Inc.

People needed

2230

Starts

2016-01-21

Expected to finish

2018-03-28

Last updated by the study team

2020-05-11

Who can join

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

You may qualify if…

• Fasting LDL-C ≥ 70 mg/dL
• High cardiovascular risk (diagnosis of HeFH or ASCVD)
• Be on maximally tolerated lipid-modifying therapy

You may not qualify if…

• 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

Where it is running

• Study site — Cottonwood, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Canoga Park, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Hartford, Connecticut, United States
• Study site — Atlantis, Florida, United States
• Study site — Boca Raton, Florida, United States
• Study site — Crestview, Florida, United States
• Study site — Crystal River, Florida, United States
• Study site — Daytona Beach, Florida, United States
• Study site — Lake Worth, Florida, United States
• Study site — Miami Lakes, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Iowa City, Iowa, United States
• Study site — Overland Park, Kansas, United States
• Study site — Covington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Minden, Louisiana, United States
• Study site — Monroe, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Auburn, Maine, United States
• Study site — Midland, Michigan, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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