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Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Esperion Therapeutics
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics
ClinicalTrials.gov Identifier:
NCT03001076
First received: December 20, 2016
Last updated: NA
Last verified: December 2016
History: No changes posted
  Purpose
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.

Condition Intervention Phase
Hypercholesterolemia
Atherosclerosis
Statin Adverse Reaction
Drug: Bempedoic acid
Drug: Ezetimibe
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Bempedoic Acid (ETC 1002) 180 mg/Day as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C

Resource links provided by NLM:


Further study details as provided by Esperion Therapeutics:

Primary Outcome Measures:
  • Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]

Estimated Enrollment: 225
Study Start Date: December 2016
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bempedoic acid
bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
Drug: Bempedoic acid
bempedoic acid 180 mg tablet
Other Name: ETC-1002
Drug: Ezetimibe
ezetimibe 10 mg tablet
Other Name: Zetia
Placebo Comparator: placebo
Matching placebo tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
Drug: Ezetimibe
ezetimibe 10 mg tablet
Other Name: Zetia
Other: Placebo
matching placebo tablet
Other Name: placebo control

  Eligibility

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

Inclusion Criteria:

  • Fasting LDL-cholesterol greater than or equal to 100 mg/dL at screening
  • Men and nonpregnant, nonlactating women
  • Use of stable lipid-modifying therapy for at least 4 weeks prior to screening that includes ezetimibe 10mg daily

Exclusion Criteria:

  • Fasting blood triglycerides greater than or equal to 500 mg/dL
  • Body Mass Index (BMI) greater than or equal to 50 kg/m2
  • Recent history of clinically significant cardiovascular disease
  • Use of statin therapy where doses are greater than those defined as "low-dose" within 4 weeks prior to screening; where "low-dose" is defined as an average daily dose of rosuvastatin 5 mg, atorvastatin 10 mg, simvastatin 10 mg, lovastatin 20 mg, pravastatin 40 mg, fluvastatin 40 mg, or pitavastatin 2 mg.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03001076

Contacts
Contact: Jeffrey C Hanselman, MS clinicaltrials@esperion.com

Locations
United States, Texas
Recruiting
Georgetown, Texas, United States, 78626
Sponsors and Collaborators
Esperion Therapeutics
Investigators
Study Director: Stephen Nash, MD Esperion Therapeutics
  More Information

Publications:
Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT03001076     History of Changes
Other Study ID Numbers: 1002-048
Study First Received: December 20, 2016
Last Updated: December 20, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Esperion Therapeutics:
hyperlididemia
LDL
cholesterol
statin intolerance

Additional relevant MeSH terms:
Atherosclerosis
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 28, 2017