NCT00530946已完成3 期
A Multi-Center, Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin In The Treatment Of Concurrent Hypertension And Hyper-LDL-Cholesterolemia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Change in Systolic Blood Pressure
研究概览
简要总结
To assess the changes in the trough Systolic Blood Pressure (SBP) and the percent changes in Low Density Lipoprotein-Cholesterol (LDL-C) from baseline at Week 8 in the treatment period
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
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The out-patient with concurrent hypertension and hyper-LDL-cholesterolemia is a male or female >=20 to <80 years of age at Visit
- •The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP >=140 mmHg and <180 mmHg,
- •LDL-C >=140 mg/dL and <250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
排除标准
- •Subjects who had experienced the following coronary artery disease within the past 3 months.
- •Myocardial infarction
- •Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
- •Any clinically meaningful valvular disease
- •Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
研究组 & 干预措施
CI-1038 2.5mg/5mg
Active Comparator
干预措施: Amlodipine 2.5mg/Atorvastatin 5mg (Drug)
CI-1038 2.5mg/10mg
Active Comparator
干预措施: Amlodipine 2.5mg/Atorvastatin 10mg (Drug)
CI-1038 5mg/5mg
Active Comparator
干预措施: Amlodipine 5mg/Atorvastatin 5mg (Drug)
CI-1038 5mg/10mg
Active Comparator
干预措施: Amlodipine 5mg/Atorvastatin 10mg (Drug)
结局指标
主要结局
Change in Systolic Blood Pressure
时间窗: 8 weeks
Value at Week 8 minus value at baseline
Percent Change in Low Density Lipoprotein-Cholesterol
时间窗: 8 weeks
Percent of "value at Week 8 minus value at baseline" over value at baseline
次要结局
- Change in Diastolic Blood Pressure From Baseline to Each Observation Point(2 weeks, 4 weeks , and 8 weeks)
- Percent Change in Low Density Lipoprotein-Cholesterol From Baseline to Each Observation Point(2 weeks, 4 weeks , and 8 weeks)
- Change in Apolipoprotein B From Baseline to Each Observation Point(2 weeks, 4 weeks, and 8 weeks)
- Percent Change in Total Cholesterol From Baseline to Each Observation Point(2 weeks, 4 weeks , and 8 weeks)
- Percent Change in Triglycerides From Baseline to Each Observation Point(2 weeks, 4 weeks , and 8 weeks)
- Change in Low Density Lipoprotein-Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (LDL-C/HDL-C) From Baseline to Each Observation Point(2 weeks, 4 weeks, and 8 weeks)
- Change in Total Cholesterol/ High Density Lipoprotein-Cholesterol Ratio (TC/HDL-C) From Baseline to Each Observation Point(2 weeks, 4 weeks , and 8 weeks)
- Change in Systolic Blood Pressure From Baseline to Each Observation Point(2 weeks, 4 weeks, and 8 weeks)
- Percent Change in High Density Lipoprotein-Cholesterol From Baseline to Each Observation Point(2 weeks, 4 weeks , and 8 weeks)
研究者
研究点 (1)
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