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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02666664
First Posted: January 28, 2016
Last Update Posted: March 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Esperion Therapeutics
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Atherosclerotic Cardiovascular Diseases Drug: ETC-1002 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Number of participants with treatment-related adverse events as assessed by MedDRA 18.1 [ Time Frame: Baseline through 52 weeks ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Enrollment: 2233
Actual Study Start Date: January 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ETC-1002
ETC-1002 180 mg/day
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
Placebo Comparator: Placebo
Placebo control
Drug: Placebo
Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02666664


  Show 98 Study Locations
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Stephen Nash, MD Esperion Therapeutics
  More Information

Additional Information:
Publications:
Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, Goldberg AC, Gordon D, Levy D, Lloyd-Jones DM, McBride P, Schwartz JS, Shero ST, Smith SC Jr, Watson K, Wilson PW, Eddleman KM, Jarrett NM, LaBresh K, Nevo L, Wnek J, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Curtis LH, DeMets D, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Smith SC Jr, Tomaselli GF; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Jun 24;129(25 Suppl 2):S1-45. doi: 10.1161/01.cir.0000437738.63853.7a. Epub 2013 Nov 12. Erratum in: Circulation. 2015 Dec 22;132(25):e396. Circulation. 2014 Jun 24;129(25 Suppl 2):S46-8.

Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT02666664     History of Changes
Other Study ID Numbers: 1002-040
2015-004136-36 ( EudraCT Number )
First Submitted: January 20, 2016
First Posted: January 28, 2016
Last Update Posted: March 16, 2017
Last Verified: March 2017

Keywords provided by Esperion Therapeutics:
hyperlipidemia
cholesterol
heterozygous familial hypercholesterolemia
atherosclerotic cardiovascular disease
ASCVD
HeFH
LDL

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypercholesterolemia
Hyperlipidemias
Hyperlipoproteinemias
Atherosclerosis
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases