Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 主要终点
- Percentage of Participants Experiencing ≥1 Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.
详细描述
This study is a long-term extension study of the protocol P00692 parent study.
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 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692).
- •If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose.
- •If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period.
- •Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study.
排除标准
- •Has discontinued from the parent study (P00692) prior to study completion.
- •Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation.
- •Is a pregnant or lactating female.
- •Is human immunodeficiency virus (HIV) positive.
研究组 & 干预措施
Placebo + Atorvastatin
Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.
干预措施: Atovastatin (Drug)
Placebo + Atorvastatin
Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study.
干预措施: Placebo (Drug)
Ezetimibe + Atorvastatin
Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study.
干预措施: Ezetimibe (Drug)
Ezetimibe + Atorvastatin
Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study.
干预措施: Atovastatin (Drug)
结局指标
主要结局
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
时间窗: Up to 12 months
Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE)
时间窗: Up to 12 months
次要结局
- Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C)(Baseline and 1.5, 3, 6, 9, and 12 months)
- Mean Percent Change from Baseline in Triglyceride Levels(Baseline and 1.5, 3, 6, 9, and 12 months)
- Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline and 1.5, 3, 6, 9, and 12 months)
- Mean Percent Change from Baseline in Total Cholesterol (TC)(Baseline and 1.5, 3, 6, 9, and 12 months)
- Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline and 1.5, 3, 6, 9, and 12 months)