Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 1,220
- Primary Endpoint
- Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Study Overview
Brief Summary
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL
- •Patient willing to be on a low-cholesterol diet
Exclusion Criteria
- •Pregnant or lactating women or intending to become pregnant
- •Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet
- •Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin
- •Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk
Arms & Interventions
Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
Intervention: Comparator: Placebo to niacin (ER) (Drug)
Part 1 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Intervention: Comparator: ezetimibe/simvastatin + niacin (ER) (Drug)
Part 1 -Arm 2
ezetimibe/simvastatin
Intervention: Comparator: Placebo to Niacin (ER) (Drug)
Part 1 - Arm 3
Niacin (ER)
Intervention: Comparator: Placebo to ezetimibe/simvastatin (Drug)
Part 1 - Arm 3
Niacin (ER)
Intervention: Comparator: niacin (ER) tablet (Drug)
Part 2 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
Intervention: Comparator: ezetimibe/simvastatin and niacin (ER) (Drug)
Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
Intervention: Comparator: ezetimibe and simvastatin (Drug)
Part 1 -Arm 2
ezetimibe/simvastatin
Intervention: Comparator: ezetimibe (+) simvastatin (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time Frame: Baseline and 24 weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time Frame: Baseline and 24 Weeks
Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline
Secondary Outcomes
- Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)(Baseline and 24 weeks)
- Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)(Baseline and 64 weeks)
- Percent Change From Baseline in Triglycerides (TG)(Baseline and 64 weeks)
- Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)(Baseline and 64 weeks)
- Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)(Baseline and 24 weeks)
- Percent Change From Baseline in Triglycerides (TG)(baseline and 24 Weeks)
- Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C)(Baseline and 64 weeks)