Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT02666664
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ETC-1002 — DRUG
    ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
  • Placebo — DRUG
    Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)

Study Details

The purpose of this study is to see if ETC-1002 (bempedoic acid) is safe and well-tolerated versus placebo in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.

Key Dates

Start date
Jan 21, 2016
Status verified
Apr 2020
Primary completion
Feb 21, 2018
Completion
Mar 28, 2018

Study Design

Enrollment
2,230 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ETC-1002
    ETC-1002 180 mg/day
  • Placebo Comparator: Placebo
    Placebo control

Primary Outcome Measure

Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 52 weeks ]

Locations (48)

FacilityCityStateZIPSite coordinators
-HuntsvilleAlabama--
-CottonwoodArizona--
-PhoenixArizona--
-Canoga ParkCalifornia--
-Santa RosaCalifornia--
-BridgeportConnecticut--
-HartfordConnecticut--
-AtlantisFlorida--
-Boca RatonFlorida--
-CrestviewFlorida--
-Crystal RiverFlorida--
-Daytona BeachFlorida--
-Lake WorthFlorida--
-Miami LakesFlorida--
-TampaFlorida--
-Park RidgeIllinois--
-Iowa CityIowa--
-Overland ParkKansas--
-CovingtonKentucky--
-LouisvilleKentucky--
-MindenLouisiana--
-MonroeLouisiana--
-ShreveportLouisiana--
-AuburnMaine--
-MidlandMichigan--
-SaginawMichigan--
-Saint CloudMinnesota--
-TupeloMississippi--
-Jefferson CityMissouri--
-NashuaNew Hampshire--
-BridgewaterNew Jersey--
-CaryNorth Carolina--
-Mount AiryNorth Carolina--
-RaleighNorth Carolina--
-Rocky MountNorth Carolina--
-WilmingtonNorth Carolina--
-CincinnatiOhio--
-SanduskyOhio--
-WilloughbyOhio--
-HillsboroOregon--
-Fort WorthTexas--
-HoustonTexas--
-KatyTexas--
-KingwoodTexas--
-OremUtah--
-RichmondVirginia--
-PuyallupWashington--
-TacomaWashington--

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