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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-29

Study Completion Date

2018-02-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia Atherosclerosis Statin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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bempedoic acid

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

Group Type EXPERIMENTAL

Bempedoic acid

Intervention Type DRUG

bempedoic acid 180 mg tablet

Ezetimibe

Intervention Type DRUG

ezetimibe 10 mg tablet

placebo

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

Group Type PLACEBO_COMPARATOR

Ezetimibe

Intervention Type DRUG

ezetimibe 10 mg tablet

Placebo

Intervention Type OTHER

matching placebo tablet

Interventions

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Bempedoic acid

bempedoic acid 180 mg tablet

Intervention Type DRUG

Ezetimibe

ezetimibe 10 mg tablet

Intervention Type DRUG

Placebo

matching placebo tablet

Intervention Type OTHER

Other Intervention Names

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ETC-1002 Zetia placebo control

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No