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

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ClinicalTrials.gov Identifier: NCT02666664
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Tracking Information
First Submitted Date  ICMJE January 20, 2016
First Posted Date  ICMJE January 28, 2016
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE January 18, 2016
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
Number of participants with treatment-related adverse events as assessed by MedDRA 18.1 [ Time Frame: Baseline through 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02666664 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2016)
  • Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: 12, 24, and 52 weeks ]
  • Percent change in high-sensitivity C-reactive protein (hs-CRP) [ Time Frame: 12, 24, and 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 25, 2016)
  • Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) [ Time Frame: 12, 24, and 52 weeks ]
  • Percent change in total cholesterol (TC) [ Time Frame: 12, 24, and 52 weeks ]
  • Percent change in apolipoprotein B (apoB) [ Time Frame: 12, 24, and 52 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony)
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled, Multicenter Long-term Safety and Tolerability Study of ETC-1002 in Patients With Hyperlipidemia at High Cardiovascular Risk Who Are Not Adequately Controlled by Their Lipid-Modifying Therapy
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypercholesterolemia
  • Atherosclerotic Cardiovascular Diseases
Intervention  ICMJE
  • Drug: ETC-1002
    ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
    Other Name: bempedoic acid
  • Drug: Placebo
    Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
Study Arms  ICMJE
  • Experimental: ETC-1002
    ETC-1002 180 mg/day
    Intervention: Drug: ETC-1002
  • Placebo Comparator: Placebo
    Placebo control
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2018)
2230
Original Estimated Enrollment  ICMJE
 (submitted: January 25, 2016)
900
Actual Study Completion Date  ICMJE March 28, 2018
Actual Primary Completion Date February 21, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fasting LDL-C ≥ 70 mg/dL
  • High cardiovascular risk (diagnosis of HeFH or ASCVD)
  • Be on maximally tolerated lipid-modifying therapy

Exclusion Criteria:

  • Total fasting triglyceride ≥500 mg/dL
  • Renal dysfunction or nephrotic syndrome or history of nephritis
  • Body Mass Index (BMI) ≥50kg/m2
  • Significant cardiovascular disease or cardiovascular event in the past 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Netherlands,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02666664
Other Study ID Numbers  ICMJE 1002-040
2015-004136-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esperion Therapeutics
Study Sponsor  ICMJE Esperion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: James Cappola, MD Esperion Therapeutics
PRS Account Esperion Therapeutics
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP