CTRI/2009/091/000683已完成3 期
An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination tablets of Nebivolol & Indapamide (as sustained release) in comparison with Nebivolol tablets in patients suffering from hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The degree of reduction in supine diastolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination tablets of Nebivolol & Indapamide (as sustained release) and Nebivolol tablets given once a day for 6 weeks in 200 patients with hypertension that will be conducted in India. The primary outcome measures will be the degree of reduction in supine diastolic blood pressure at the end of the study as compared to the baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either sex 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
- •2.Patients with hypertension (defined as supine systolic and/or diastolic blood pressure more than 140 mm Hg and 90 mm Hg respectively) 3.Informed consent of the patient/relative.
排除标准
- •1.Pregnancy and/or Lactation 2.Patients with anuria, progressive & severe oliguria, hepatic coma, hyponatremia, hypokalaemia, hyperuricemia, secondary hypertension, systemic lupus erythematosus 3.Patients with bronchial asthma, diabetes, thyrotoxicosis, peripheral vascular disease, severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure or sick sinus syndrome 4.Patients with hepatic and /or renal dysfunction 5.Patients with a history of known hypersensitivity to either Nebivolol or Indapamide or to other sulfonamide derivatives or to any other component of the study drugs 6.Patients with any other serious concurrent illness or malignancy 7.Patients with continuing history of alcohol and / or drug abuse 8.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
The degree of reduction in supine diastolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)
时间窗: 2,4 & 6 weeks
次要结局
- The degree of reduction in supine systolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)(2,4 & 6 weeks)
研究者
研究点 (5)
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