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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)

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ClinicalTrials.gov Identifier: NCT03001076
Recruitment Status : Completed
First Posted : December 22, 2016
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE December 22, 2016
Last Update Posted Date March 29, 2019
Actual Study Start Date  ICMJE November 29, 2016
Actual Primary Completion Date January 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03001076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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
Brief Summary 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.
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
  • Atherosclerosis
  • Statin Adverse Reaction
Intervention  ICMJE
  • Drug: Bempedoic acid
    bempedoic acid 180 mg tablet
    Other Name: ETC-1002
  • Drug: Ezetimibe
    ezetimibe 10 mg tablet
    Other Name: Zetia
  • Other: Placebo
    matching placebo tablet
    Other Name: placebo control
Study Arms  ICMJE
  • Experimental: bempedoic acid
    bempedoic acid 180 mg tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
    Interventions:
    • Drug: Bempedoic acid
    • Drug: Ezetimibe
  • Placebo Comparator: placebo
    Matching placebo tablet taken orally, daily. Patients remain on ongoing ezetimibe therapy (study provided)
    Interventions:
    • Drug: Ezetimibe
    • Other: 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: November 6, 2017)
269
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2016)
225
Actual Study Completion Date  ICMJE February 12, 2018
Actual Primary Completion Date January 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03001076
Other Study ID Numbers  ICMJE 1002-048
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Esperion Therapeutics
Study Sponsor  ICMJE Esperion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Narendra Lalwani, PhD 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