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)

Part of paid clinical trials in Georgetown, Texas.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT03001076
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bempedoic acid — DRUG
    bempedoic acid 180 mg tablet
  • Ezetimibe — DRUG
    ezetimibe 10 mg tablet
  • Placebo — OTHER
    matching placebo tablet

Study Details

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 Dates

Start date
Nov 29, 2016
Status verified
Apr 2020
Primary completion
Jan 11, 2018
Completion
Feb 12, 2018

Study Design

Enrollment
269 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bempedoic acid
    bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
  • Placebo Comparator: placebo
    Matching placebo tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)

Primary Outcome Measure

Percent Change From Baseline to Week 12 in Low-Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Week 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-GeorgetownTexas78626-

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