Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction

In brief

The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.

Key facts

Study ID

NCT03001076

Run by

Esperion Therapeutics, Inc.

People needed

269

Starts

2016-11-29

Expected to finish

2018-02-12

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-cholesterol greater than or equal to 100 mg/dL at screening
• Men and nonpregnant, nonlactating women
• Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that includes ezetimibe 10mg daily

You may not qualify if…

• Fasting blood triglycerides greater than or equal to 500 mg/dL
• Body Mass Index (BMI) greater than or equal to 50 kg/m2
• Recent history of clinically significant cardiovascular disease
• Use of statin therapy where doses are greater than those defined as "low-dose" within 4 weeks prior to screening; where "low-dose" is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.

Where it is running

• Study site — Georgetown, Texas, United States

Full record on ClinicalTrials.gov

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