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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
382
bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
bempedoic acid 180 mg tablet
ezetimibe 10 mg overencapsulated tablet
PMG Research of McFarland
Ames, Iowa, United States
Foundation Cardiology
Nashua, New Hampshire, United States
PMG Research of Piedmont Healthcare
Statesville, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Percent Change From Baseline to Week 12 in Low-density Lipoprotein Cholesterol (LDL-C)
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.
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in High-sensitivity C-reactive Protein (hsCRP)
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.
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
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.
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
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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
PMG Research of Knoxville
Knoxville, Tennessee, United States
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.
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Apolipoprotein B (Apo B)
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.
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in High-density Lipoprotein Cholesterol (HDL-C)
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.
Time frame: Baseline; Week 12
Percent Change From Baseline to Week 12 in Triglycerides (TGs)
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.
Time frame: Baseline; Week 12