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
- Conditions
- Hyperlipidemias
- Interventions
- Combination Product: Bempedoic Acid + Ezetimibe Fixed-Dose CombinationDrug: Placebos
- Registration Number
- NCT03337308
- Lead Sponsor
- Esperion Therapeutics, Inc.
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 382
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EZE 10 mg Placebos Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks BA 180 mg + EZE 10 mg FDC Placebos Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks BA 180 mg + EZE 10 mg FDC Bempedoic Acid + Ezetimibe Fixed-Dose Combination Bempedoic acid (BA) + ezetimibe (EZE) fixed-dose combination (FDC) 180 mg/10 mg tablets taken orally once daily for 12 weeks Placebos 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 BA 180 mg Placebos Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks EZE 10 mg Ezetimibe Ezetimibe (EZE) 10 mg overencapsulated tablets taken orally once daily for 12 weeks BA 180 mg Bempedoic Acid Bempedoic acid (BA) 180 mg tablets taken orally once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C) 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.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) 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 High-sensitivity C-reactive Protein (hsCRP) 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 Total Cholesterol (TC) 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) 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) 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) 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.
Trial Locations
- Locations (5)
Foundation Cardiology
🇺🇸Nashua, New Hampshire, United States
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
PMG Research of McFarland
🇺🇸Ames, Iowa, United States
PMG Research of Piedmont Healthcare
🇺🇸Statesville, North Carolina, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States