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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,220
- 主要终点
- Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
研究概览
简要总结
To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
干预措施: Comparator: Placebo to niacin (ER) (Drug)
Part 1 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
干预措施: Comparator: ezetimibe/simvastatin + niacin (ER) (Drug)
Part 1 -Arm 2
ezetimibe/simvastatin
干预措施: Comparator: Placebo to Niacin (ER) (Drug)
Part 1 - Arm 3
Niacin (ER)
干预措施: Comparator: Placebo to ezetimibe/simvastatin (Drug)
Part 1 - Arm 3
Niacin (ER)
干预措施: Comparator: niacin (ER) tablet (Drug)
Part 2 - Arm 1
ezetimibe/simvastatin combination tablet + niacin (ER)
干预措施: Comparator: ezetimibe/simvastatin and niacin (ER) (Drug)
Part 2 - Arm 2
ezetimibe/simvastatin combination tablet + niacin (Pbo)
干预措施: Comparator: ezetimibe and simvastatin (Drug)
Part 1 -Arm 2
ezetimibe/simvastatin
干预措施: Comparator: ezetimibe (+) simvastatin (Drug)
结局指标
主要结局
Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
时间窗: 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)
时间窗: 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
次要结局
- 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)