Long-Term, Open-Label, Safety and Tolerability Study of Ezetimibe (SCH 58235) in Addition to Atorvastatin in Subjects With Coronary Heart Disease or Multiple Risk Factors and With Primary Hypercholesterolemia Not Controlled by a Starting Dose (10 mg) of Atorvastatin
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 432
- 主要终点
- Number of participants who experienced an adverse event
研究概览
简要总结
The purpose of this study was to evaluate the long-term safety and tolerability of ezetimibe 10 mg once daily co-administered with atorvastatin 10 to 80 mg daily for up to 12 consecutive months in participants with heterozygous familial hypercholesterolemia (HeFH) or in participants with coronary heart disease (CHD) or multiple cardiovascular risk factors and primary hypercholesterolemia not controlled by a starting dose (10 mg daily) of atorvastatin.
详细描述
Adult participants with a diagnosis of HeFH or CHD or multiple risk factors (≥2) and with primary hypercholesterolemia who had successfully completed the 14-week, double-blind efficacy and safety study of ezetimibe co-administered with atorvastatin (Protocol No. P00693/MK-0653-030; NCT03867318) were eligible for enrollment in this long-term extension study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have successfully completed the 14-week double-blind, efficacy and safety study of SCH 58235 in addition to atorvastatin in participants with CHD or multiple risk factors or HeFH, (Protocol P00693/MK-0653-030; NCT03867318). Entry into this protocol must occur at the time of completion of Protocol P00693/MK-0653-030; NCT03867318
- •All women must have a negative pregnancy test prior to study entry. Women of child bearing potential must agree to practice an effective barrier method of birth control for the duration of the study. In addition, participants must agree to practice an effective barrier method of birth control for 30 days following the last dose of atorvastatin administered
- •Postmenopausal women who are receiving postmenopausal hormonal therapy or raloxifene must be maintained on a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen during study period
排除标准
- •Participants who discontinued from the Protocol P00693 due to adverse events or poor compliance
- •Pregnant or lactating women
- •Participants who are known to be HIV positive
研究组 & 干预措施
Ezetimibe 10 mg + Atorvastatin
Ezetimibe 10 mg plus atorvastatin 10 to 80 mg daily for up to 12 months
干预措施: Ezetimibe (Drug)
Ezetimibe 10 mg + Atorvastatin
Ezetimibe 10 mg plus atorvastatin 10 to 80 mg daily for up to 12 months
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Number of participants who experienced an adverse event
时间窗: Up to 12 months
Number of participants who discontinued study drug due to an adverse event
时间窗: Up to 12 months
次要结局
- Change from baseline in LDL-C levels(Up to 12 months)
- Change from baseline in triglyceride levels(Up to 12 months)
- Change from baseline in HDL-C levels(Up to 12 months)
- Percentage of participants achieving target LDL-C level (≤100 mg/dL)(Up to 12 months)