NCT00297973已完成4 期
Cardiovascular Risk Assessment In Patients With Hypertension And At Least Three Other Risk Factors, Treated With Caduet Compared To Usual Care: The Right Study
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.385 个研究点 分布在 1 个国家目标入组 1,442 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,442
- 试验地点
- 385
- 主要终点
- % reduction in Framingham's predicted 10-year risk of a coronary event between V1 and V3 in the Caduet group compared to the usual care group (6) (including diabetic patients)
研究概览
简要总结
Compare the reduction in Framingham's predicted 10-year risk of a coronary event (6) in patients with hypertension and at least three other cardiovascular risk factors (including diabetic patients) seen in private practice and randomized to either Caduet or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •1.Male or female, 18 years of age or over, 2.Patient with hypertension and at least three other CV risk factors, 3.Hypertension, treated or not, but not at the currently recommended goals (140/90 mmHg for most patients, 130/80 mmHg for patients with diabetes or nephropathy). In case of treated hypertension, patients should be on their current treatment for at least 4 weeks before randomisation,
排除标准
- •1. Patient with a history of coronary heart disease, 2.Patients with a history of familial hypercholesterolemia, 3.Patient with malignant HTN, 4.Non-essential hypertension, 5.Known hypersensitivity to dihydropyridines, 6.Patients already receiving a dihydropyridine, 7.Known hypersensitivity to HMG-CoA-reductase inhibitors, 8.Patients currently receiving or who has received a HMG-CoA-reductase within the 3 months prior to selection, 9.Patients currently receiving or who has received a fibric acid, resins, ezetimibe, nicotinic acid and all other drug which is known to affect lipid levels, within 6 weeks prior to selection,
结局指标
主要结局
% reduction in Framingham's predicted 10-year risk of a coronary event between V1 and V3 in the Caduet group compared to the usual care group (6) (including diabetic patients)
次要结局
- 1. % patients changing risk category between V1 and V3 2. % reduction in Framingham's predicted 10-year risk of a coronary event (8) excluding diabetic patients 3. Clinical and biological safety during treatment period
研究者
研究点 (385)
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