CTRI/2011/07/001879招募中4 期
Evaluation of effect of Coversyl-AM on Peripheral and Central Aortic Blood Pressure In Daily Clinical Practice
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Reduction of peripheral & central aortic blood pressure from baseline to end of study
研究概览
简要总结
This study is proposed to evaluate the effect of fixed combination of amlodipine-perindopril on peripheral as well as central aortic pressures in ’real world’ daily clinical setting in India.
It is an open-label, prospective, non-comparative, phase-IV study planned to be conducted in 200 hypertensive patients in 2 centers. The treatment duration is for a period of 1 year and includes 5 visits (including the inclusion and end of study visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 79.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients between 40 years to 79 years of age •Hypertensive patients who is either: a.Newly diagnosed, untreated moderate to severe hypertensive patients with SBP≥160 mm Hg and /or DBP≥100 mm Hg b.Patients inadequately controlled (SBP≥140 mm Hg and /or DBP ≥90 mm Hg) on monotherapy c.Patients inadequately controlled (SBP≥140 mm Hg and /or DBP ≥90 mm Hg) on any other combination therapy (given separately or as fixed-dose combination) •Given written informed consent to participate in the study and agree for regular follow-up.
排除标准
- •Previous myocardial infarction •Presently treated angina •Cerebrovascular event within the previous 3 months •Uncontrolled arrhythmia •Heart failure •Severe hepatic/ renal abnormalities •Galactosemia •Any contraindication to an ACE inhibitor and/or CCB •Any clinically important hematological or biochemical abnormality •Pregnancy/ Lactation.
结局指标
主要结局
Reduction of peripheral & central aortic blood pressure from baseline to end of study
时间窗: Month 0, Month 3, Month 6, Month 9 & Month 12
次要结局
- Safety profile(Month 0, Month 3, Month 6, Month 9 & Month 12)
研究者
研究点 (2)
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