To assess the safety and effectiveness of telmisartan/amlodipine in comparison to telmisartan in Indian patients with hypertension through a real-world, retrospective, Observational study (CONTROL Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14,000
- 试验地点
- 1
- 主要终点
- 1. Mean change in seated SBP & DBP
研究概览
简要总结
This is a real-world, retrospective, observational, open-label study with an objective to evaluate the tolerability and effectiveness of telmisartan and amlodipine combination in comparison to telmisartan monotherapy as initial-line therapy in treatment-naïve Indian adults with newly diagnosed hypertension.
The Endpoints of the study are as follows-
- Primary Endpoints:
- Mean change in seated SBP & DBP from baseline at 12±2 weeks
- Secondary Endpoints:
-
Proportion of patients achieving BP control (defined as mean seated SBP <130 mmHg and DBP <80 mmHg) at 12±2 weeks.
-
Proportion of patients who sustained or improved on BP control achieved at 12±2 weeks over 24±2 weeks
-
Incidence of adverse events
Data of approximately 14,000 patients across India will be collected for the purpose of this study. The available data must meet all the following criteria to be included in the study:
1. Inclusion Criteria
-
Adult Male or female patients with newly diagnosed hypertension (BP >140/90 mmHg)
-
Patients diagnosed with hypertension and treated with telmisartan & amlodipine combination or telmisartan monotherapy as initial line therapy
- Exclusion Criteria
- Patients with current or past exposure to antihypertensive medications other than study drug
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult Male or female patients with newly diagnosed hypertension (BP more than 140/90 mmHg)
- •Patients diagnosed with hypertension and treated with telmisartan & amlodipine combination or telmisartan monotherapy as initial line therapy.
排除标准
- •Patients with current or past exposure to antihypertensive medications other than study drug.
结局指标
主要结局
1. Mean change in seated SBP & DBP
时间窗: from baseline at 12±2 weeks
次要结局
- 1. Proportion of patients achieving BP control (defined as mean seated SBP less than 130 mmHg and DBP less than 80 mmHg).(at 12±2 weeks)
- 2. Proportion of patients who sustained or improved on BP control achieved(at 12±2 weeks over 24±2 weeks)
- 3. Incidence of adverse events(at any subsequent visit post baseline)
研究者
Dr Mukesh Gabhane
Torrent Pharmaceuticals Ltd.
