CTRI/2024/03/064100进行中（未招募）4 期
A multicentric, open label study to evaluate the safety and efficacy of fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets in the management of Stage II hypertension.
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Number of patients reporting incidences of adverse events
研究概览
简要总结
This is an open-label trial to evaluate the safety and efficacy of the fixed-dose combination of Efonidipine 40 mg and Telmisartan 40 mg tablets in Stage II hypertension. The adverse events will be monitored during the 90 days of treatment period. The efficacy in reducing blood pressure and a number of patients achieving or maintaining the target blood pressure will be evaluated in this Phase IV trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with age 18 years and above
- •Patients diagnosed with Stage II hypertension (SBP/DBP: 160/100 mmHg or above)
- •Naïve patients or patients able to switch from their current antihypertensive therapy without any risk to the patient on the investigator opinion
- •Patients willing to sign informed consent.
排除标准
- •Patients with known hypersensitivity to angiotensin II receptor blockers or dihydropyridine calcium channel blockers
- •Patients with history of severe, malignant or secondary hypertension
- •Patient with cerebrovascular disease in the previous 3 months
- •Patients with chronic arrhythmia, sick sinus syndrome or sinus bradycardia (less than 50 beats per min)
- •Patients with second or third degree atrioventricular block
- •Female patients who are pregnant, lactating.
结局指标
主要结局
Number of patients reporting incidences of adverse events
时间窗: Day 0 to Day 90
次要结局
- Mean reduction in sitting Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)(Day 30, 60 and 90)
- Number of patients achieving/maintaining the target BP as per JNC VIII guideline for Hypertension.(Day 90)
研究者
Dr Bhupesh Dewan
Zuventus Healthcare Limited
研究点 (4)
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