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)

• Status: Completed
• Trial end date: 2018-02-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.