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Trial record 1 of 1 for:    1002FDC-053
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A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

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.
 
ClinicalTrials.gov Identifier: NCT03337308
Recruitment Status : Completed
First Posted : November 8, 2017
Results First Posted : April 8, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Tracking Information
First Submitted Date  ICMJE November 6, 2017
First Posted Date  ICMJE November 8, 2017
Results First Submitted Date  ICMJE March 25, 2020
Results First Posted Date  ICMJE April 8, 2020
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE October 23, 2017
Actual Primary Completion Date June 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline; Week 12 ]
Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for LDL-C. Baseline was defined as the mean of the LDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in LDL-C was analyzed using analysis of covariance (ANCOVA) with treatment group and randomization stratification as a factors and baseline LDL-C as a covariate. Percent change from baseline was calculated as: ([LDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100. For LDL-C, if measured LDL-C value was available, measured LDL-C was used.
Original Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
Percent change in low-density lipoprotein cholesterol (LDL-C) [ Time Frame: Baseline through 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2020)
  • Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: Baseline; Week 12 ]
    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for hsCRP. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in hsCRP was analyzed using a non-parametric analysis. Percent change from baseline was calculated as: ([hsCRP value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
  • Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) [ Time Frame: Baseline; Week 12 ]
    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for non-HDL-C. Baseline was defined as the mean of the non-HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline in non-HDL-C was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline non-HDL-C as a covariate. Percent change from baseline was calculated as: ([non-HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
  • Percent Change From Baseline to Week 12 in Total Cholesterol (TC) [ Time Frame: Baseline; Week 12 ]
    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TC. Baseline was defined as the mean of the TC values from Week -2 and predose Day 1/Week 0. Percent change from baseline in TC was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline TC as a covariate. Percent change from baseline was calculated as: ([TC value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
  • Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B) [ Time Frame: Baseline; Week 12 ]
    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for apo B. Baseline was defined as the predose Day 1/Week 0 value. Percent change from baseline in apo B was analyzed using ANCOVA with treatment group and randomization stratification as a factors and baseline apo B as a covariate. Percent change from baseline was calculated as: ([apo B value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
  • Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C) [ Time Frame: Baseline; Week 12 ]
    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for HDL-C. Baseline was defined as the mean of the HDL-C values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([HDL-C value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
  • Percent Change From Baseline to Week 12 in Triglycerides (TGs) [ Time Frame: Baseline; Week 12 ]
    Blood samples were drawn after a minimum 10-hour fast (water was allowed) at pre-specified intervals. Samples were collected and analyzed for TGs. Baseline was defined as the mean of the TGs values from Week -2 and predose Day 1/Week 0. Percent change from baseline was calculated as: ([TGs value at Week 12 minus Baseline value] divided by [Baseline Value]) multiplied by 100.
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 A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy
Official Title  ICMJE A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy
Brief Summary The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hyperlipidemias
Intervention  ICMJE
  • Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination
    bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
    Other Names:
    • Bempedoic Acid + Zetia FDC
    • ETC-1002 + Zetia
  • Drug: Bempedoic Acid
    bempedoic acid 180 mg tablet
    Other Name: ETC-1002
  • Drug: Ezetimibe
    ezetimibe 10 mg overencapsulated tablet
    Other Name: Zetia
  • Drug: Placebos
    placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: BA 180 mg + EZE 10 mg FDC
    Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks
    Interventions:
    • Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose Combination
    • Drug: Placebos
  • Experimental: BA 180 mg
    Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks
    Interventions:
    • Drug: Bempedoic Acid
    • Drug: Placebos
  • Active Comparator: EZE 10 mg
    Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks
    Interventions:
    • Drug: Ezetimibe
    • Drug: Placebos
  • Placebo Comparator: Placebos
    Placebos to match identical bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or identical bempedoic acid 180 mg tablet, or identical ezetimibe 10 mg capsule, taken orally, once daily for 12 weeks
    Intervention: Drug: Placebos
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: September 21, 2018)
382
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
350
Actual Study Completion Date  ICMJE July 18, 2018
Actual Primary Completion Date June 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Require lipid-modifying therapy for primary or secondary prevention of cardiovascular disease
  • Fasting LDL-C ≥ 130 mg/dL for primary prevention or LDL-C ≥ 100 mg/dL for secondary prevention (history of HeFH and/or ASCVD)
  • Treated with maximally tolerated statin therapy at stable dose for at least 4 weeks prior to screening

Exclusion Criteria:

  • Total Fasting Triglyceride ≥ 400 mg/dL
  • Renal Dysfunction or nephrotic syndrome or history of nephritis
  • Significant cardiovascular disease or cardiovascular event within 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03337308
Other Study ID Numbers  ICMJE 1002FDC-053
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Esperion Therapeutics
Study Sponsor  ICMJE Esperion Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ron Haberman, MD Esperion Therapeutics
PRS Account Esperion Therapeutics
Verification Date March 2020

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