跳至主要内容
临床试验/CTRI/2026/01/100848
CTRI/2026/01/100848尚未招募不适用

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)

Torrent Pharmaceuticals Ltd.3 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年1月25日最近更新:

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-

  1. Primary Endpoints:
  • Change in SBP and DBP
  1. 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

发起方
Torrent Pharmaceuticals Ltd.
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Dr Lokesh R V

Torrent Pharmaceuticals Ltd.

研究点 (3)

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