Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT02988115
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
  • placebo — OTHER
    Matching placebo tablet

Study Details

The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.

Key Dates

Start date
Nov 16, 2016
Status verified
Mar 2020
Primary completion
Mar 16, 2018
Completion
Mar 16, 2018

Study Design

Enrollment
345 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 lipid-modifying therapy (not study provided)
  • Placebo Comparator: placebo
    Matching placebo tablet taken orally, daily. Patients remain on ongoing lipid-modifying therapy (not study provided)

Primary Outcome Measure

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

Locations (52)

FacilityCityStateZIPSite coordinators
-GilbertArizona--
-AnaheimCalifornia--
-Long BeachCalifornia--
-SacramentoCalifornia--
-Santa AnaCalifornia--
-TorranceCalifornia--
-VenturaCalifornia--
-HamdenConnecticut--
-Daytona BeachFlorida--
-Fort LauderdaleFlorida--
Site 1MiamiFlorida--
Site 2MiamiFlorida--
-OrlandoFlorida--
-West Palm BeachFlorida--
-AtlantaGeorgia--
-SavannahGeorgia--
-MeridianIdaho--
-EvanstonIllinois--
-EvansvilleIndiana--
-Iowa CityIowa--
-WaterlooIowa--
-MonroeLouisiana--
-SlidellLouisiana--
-TupeloMississippi--
-LincolnNebraska--
-SomersetNew Jersey--
-BinghamtonNew York--
-EndwellNew York--
-New WindsorNew York--
-GreensboroNorth Carolina--
-MorgantonNorth Carolina--
-Mount AiryNorth Carolina--
-ColumbusOhio--
-MarionOhio--
-MaumeeOhio--
-Oklahoma CityOklahoma--
-BeaverPennsylvania--
-LanghornePennsylvania--
-CumberlandRhode Island--
-AndersonSouth Carolina--
-SummervilleSouth Carolina--
-JacksonTennessee--
-KnoxvilleTennessee--
-MemphisTennessee--
-AmarilloTexas--
Site 1DallasTexas--
Site 2DallasTexas--
-HoustonTexas--
-San AntonioTexas--
-ClintonUtah--
-HamptonVirginia--
-KenoshaWisconsin--

Find similar trials in Gilbert, AZ

By research site
Site 1· Miami, FLSite 2· Miami, FLSite 1· Dallas, TXSite 2· Dallas, TX

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