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)

Esperion Therapeutics

Status and phase: Completed; Phase 3

Conditions: Statin Adverse Reaction; Hypercholesterolemia; Atherosclerosis

Treatments: Drug: Ezetimibe; Other: Placebo; Drug: Bempedoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT03001076

1002-048

Details and patient eligibility

About

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.

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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269 participants in 2 patient groups, including a placebo group

bempedoic acid

Experimental group

Description:

bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)

Treatment:

Drug: Bempedoic acid

Drug: Ezetimibe

placebo

Placebo Comparator group

Description:

Matching placebo tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)

Treatment:

Other: Placebo

Drug: Ezetimibe