A Retrospective, Observational, Multicentric Study Targeted to assess the Effectiveness, Tolerability and Preferred Patient Profile for Fixed Dose Combination of Telmisartan and Metoprolol in Indian Patients with Hypertension (TARGET BETA-2 Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10,000
- 试验地点
- 3
- 主要终点
- 1. Change in SBP and DBP
研究概览
简要总结
This is a real world, retrospective, multicentric, observational study wherein data of patients visiting to various clinics across India are collected in suitably designed Data Collection Form (DCF).
The objective of the study is to retrospectively access the effectiveness, tolerability and preferred patient profiles for FDC of Telmisartan and Metoprolol in the management of Hypertension in real world outpatient settings of India.
STUDY ENDPOINTS are as follows-
- Primary Endpoints:
- Change in SBP and DBP
- Secondary Endpoints:
- Change in heart rate in patients with and without tachycardia
- Patient profile and time taken (in years) to switchover to dual therapy from monotherapy.
- Proportion of naïve hypertensives, started with dual therapy
Data for approximately 10,000 patients across India will be collected for the purpose of this study who meets the following criteria-
- Patients who were prescribed FDC of Telmisartan and Metoprolol XR (any dosage)
The present study is a retrospective data collection study. Basic statistical analysis will be performed on all collected data. The data will be compiled, and subjected to analysis.
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
- •Patients who were prescribed FDC of Telmisartan and Metoprolol XR (any dosage).
排除标准
- 未提供
结局指标
主要结局
1. Change in SBP and DBP
时间窗: Baseline and Post 30 days
次要结局
- 1. Change in heart rate in patients with and without tachycardia.(Baseline and Post 30 days)
- 1. Patient profile and time taken (in years) to switchover to dual therapy from monotherapy.(2. Proportion of naïve hypertensives, started with dual therapy.)
研究者
Dr Lokesh R V
Torrent Pharmaceuticals Ltd.
