A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

Part of paid clinical trials in Ames, Iowa.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT03337308
Phase
PHASE3
Status
Completed

Conditions

  • Hyperlipidemias

Eligibility Criteria

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

Interventions

  • Bempedoic Acid + Ezetimibe Fixed-Dose Combination — COMBINATION_PRODUCT
    bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
  • Bempedoic Acid — DRUG
    bempedoic acid 180 mg tablet
  • Ezetimibe — DRUG
    ezetimibe 10 mg overencapsulated tablet
  • Placebos — DRUG
    placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule

Study Details

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.

Key Dates

Start date
Oct 23, 2017
Status verified
Mar 2020
Primary completion
Jun 18, 2018
Completion
Jul 18, 2018

Study Design

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

Arms

  • Experimental: BA 180 mg + EZE 10 mg FDC
    Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks
  • Experimental: BA 180 mg
    Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks
  • Active Comparator: EZE 10 mg
    Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks
  • Placebo Comparator: Placebos
    Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks

Primary Outcome Measure

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

Locations (5)

FacilityCityStateZIPSite coordinators
PMG Research of McFarlandAmesIowa50010-
Foundation CardiologyNashuaNew Hampshire03060-
PMG Research of Piedmont HealthcareStatesvilleNorth Carolina28625-
PMG Research of WilmingtonWilmingtonNorth Carolina28401-
PMG Research of KnoxvilleKnoxvilleTennessee37912-

Find similar trials in Ames, IA

By research site
PMG Research of McFarland· Ames, IAFoundation Cardiology· Nashua, NHPMG Research of Piedmont Healthcare· Statesville, NCPMG Research of Wilmington· Wilmington, NCPMG Research of Knoxville· Knoxville, TN

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