Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C

Part of paid clinical trials in Champaign, Illinois.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT03051100
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Bempedoic acid 180mg — DRUG
    bempedoic acid 180 mg
  • Ezetimibe 10mg — DRUG
    ezetimibe 10 mg
  • Atorvastatin 20mg — DRUG
    atorvastatin 20 mg
  • Placebo — OTHER
    placebo

Study Details

The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.

Key Dates

Start date
Jan 19, 2017
Status verified
Mar 2020
Primary completion
Jun 1, 2017
Completion
Jul 5, 2017

Study Design

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

Arms

  • Experimental: Triplet Therapy
    Bempedoic acid 180 mg, ezetimibe 10 mg, and atorvastatin 20 mg taken orally, daily.
  • Placebo Comparator: placebo
    Matching placebos taken orally, daily.

Primary Outcome Measure

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6 [ Time Frame: Baseline; Week 6 ]

Locations (11)

FacilityCityStateZIPSite coordinators
PMG Research of Christie ClinicChampaignIllinois61820-
PMG Research of CaryCaryNorth Carolina27518-
PMG Research of CharlotteCharlotteNorth Carolina28209-
Sensenbrenner Primary CareCharlotteNorth Carolina28277-
PMG Research of HickoryHickoryNorth Carolina28601-
PMG Research of RaleighRaleighNorth Carolina27609-
PMG Research of Rocky MountRocky MountNorth Carolina27804-
PMG Research SalisburySalisburyNorth Carolina28144-
PMG Research of WilmingtonWilmingtonNorth Carolina28401-
PMG Research of CharlestonMt. PleasantSouth Carolina29464-
Hampton Roads Center for Clinical ResearchVirginia BeachVirginia23451-

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