NCT00332761已完成4 期
An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial Examining The Efficacy And Safety Of Caduet® In Simultaneously Achieving Blood Pressure And Lipid Goals In An Untreated Hypertensive And Dyslipidemic Subject Population. (CUSP - Caduet in Untreated Subject Population)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.35 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2006年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 35
- 主要终点
- The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
研究概览
简要总结
The purpose of this study is to determine if Caduet will lower blood pressure to <140/90 mmHg and lower LDL Cholesterol to <100 mg/dL in subjects with hypertension and dyslipidemia who are not currently being treated for these medical conditions.
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
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who were recently diagnosed with both hypertension and dyslipidemia and who are not yet taking any medications for these conditions OR subjects with both hypertension and dyslipidemia who were previously treated with antihypertensive and/or lipid lowering medications but discontinued these medications for at least 3 months prior to the Screening visit.
- •SBP 140-169 mmHg and/or DBP 90-105 mmHg, LDL-C 110-160 mg/dL
排除标准
- •Subjects with a history of MI, angina, coronary artery bypass or intra-coronary interventions, stroke, TIA, CHF or cardiomyopathy requiring treatment.
- •Subjects with a known history of Type I or Type 2 Diabetes Mellitus or a fasting blood glucose > 126 mg/dL at the Screening visit.
结局指标
主要结局
The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 4.
次要结局
- The percentage of subjects achieving both blood pressure goal (<140/90 mmHg) and LDL-C goal (<100 mg/dL) at Week 8.
- Change from Baseline to Week 4 in SBP, DBP, and Framingham 10-year CHD risk score.
- Percent change from Baseline to Week 4 in LDL-C, HDL, TC, and TG.
- The percentage of study subjects achieving each of the following goals at Week 4: SBP, DBP, and LDL-C.
- Change from Baseline to Week 8 in SBP, DBP, and Framingham 10-year CHD risk score.
- Percent change from Baseline to Week 8 in LDL-C, HDL, TC, and TG.
- The percentage of study subjects achieving each of SBP, DBP, and LDL-C goals at Week 8.
研究者
研究点 (35)
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