CTRI/2010/091/000632已完成4 期
Efficacy and tolerability of Bisoprolol in patients with newly diagnosed Stage I essential hypertension.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 255
- 主要终点
- Percentage of patients achieving BP < 140/ 90 mm Hg
研究概览
简要总结
This is a Non randomized, uncontrolled, observational study To assess the Efficacy & Tolerability of CONCOR inpatients with newly diagnosed Stage I essential hypertension according to JNC 7 all over India across 300 centres.
研究设计
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Newly diagnosed JNC 7 Stage I essential hypertension 2 Patient advised CONCOR (Bisoprolol) 3 No other clinically significant co-morbidities.
排除标准
- •1 Any contraindications to CONCOR2 Uncontrolled diabetes (Any ongoing symptoms or complication related to Diabetes)3 Females in childbearing age not willing to use a reliable mean of contraception4 Confirmed diagnosis of any CVD except Hypertension.
结局指标
主要结局
Percentage of patients achieving BP < 140/ 90 mm Hg
时间窗: At the end of 12 weeks(responder).
次要结局
- (1) Average reduction in systolic and diastolic BP. (2) Average time to reach target BP (in responders). (3) Average dose required to control (in responders). (4) Average reduction in Heart Rate. (5) Assessment of compliance at 12 weeks (pill count). (6) Blood Glucose parameters. (7) Renal parameter status(At the end of 12 weeks(responder).)
研究者
研究点 (255)
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