NCT00407537已完成4 期
A Cluster Randomized Trial On Cardiovascular Risk Factor Management: Caduet Versus Usual Care In Subjects With Hypertension And Additional Cardiovascular Risk Factors In Clinical Practice
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 1,531 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,531
- 试验地点
- 1
- 主要终点
- Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
研究概览
简要总结
To investigate whether a Caduet based treatment strategy might result in greater reduction in total cardiovascular risk as compared to usual care in subjects with hypertension and additional risk factors.
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
- 35 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension with three additional risks factors (for example: smoking, type 2 diabetes, family history of early heart disease, history of stroke, age over 55 (men) and 65 (women)
排除标准
- •Subjects currently receiving a statin or stopped statin within 6 months prior to enrollment.
- •Subjects with a history of myocardial infarction and subjects with coronary bypass graft or intra-coronary interventions.
研究组 & 干预措施
Caduet
Experimental
Open label caduet added to usual care regimen followed by investigators.
干预措施: Amlodipine besylate/atorvastatin calcium single pill combination (Drug)
结局指标
主要结局
Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12
时间窗: Baseline, Month 12
Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).
次要结局
- Change From Baseline in Systolic Blood Pressure (SBP) at Month 4(Baseline, Month 4)
- Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4(Baseline, Month 4)
- Change From Baseline in SBP at Month 12(Baseline, Month 12)
- Change From Baseline in DBP at Month 12(Baseline, Month 12)
- Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months(Month 4, Month 12)
- Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months(Month 4, Month 12)
- Mean Lipid Parameters at Month 12(Month 12)
- Change From Baseline in Lipid Parameters at Month 4(Baseline, Month 4)
- Mean Systolic and Diastolic Blood Pressure at Month 12(Month 12)
- Framingham 10-year Risk of Total CHD at Month 4(Baseline, Month 4)
- European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12(Baseline, Month 12)
- European SCORE 10-year Risk of Fatal CVD at Month 4(Baseline, Month 4)
- Framingham 10-year Risk of Stroke at Month 12(Baseline, Month 12)
- Framingham 10-year Risk of Stroke at Month 4(Baseline, Month 4)
- Change From Baseline in Framingham 10-year Risk of Developing Total CHD(Baseline, Month 4, Month 12)
- Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD(Baseline, Month 4, Month 12)
- Mean Systolic and Diastolic Blood Pressure at Month 4(Month 4)
- Mean Lipid Parameters at Month 4(Month 4)
- Number of Participants With Increase of Treatment Dosages After 4 Months.(Month 4)
- Change From Baseline in Lipid Parameters at Month 12(Baseline, Month 12)
- Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months(Month 4, Month 12)
研究者
研究点 (1)
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