跳至主要内容
临床试验/CTRI/2025/08/093314
CTRI/2025/08/093314尚未招募不适用

Drug utilization pattern and tolerability of Nebivolol-Telmisartan combination in Indian Hypertensive Patients: A retrospective cross-sectional study (INTEL-HT)

Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2025年9月1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
15,000
试验地点
1
主要终点
1. Proportion of patients with hypertension on FDC of Nebivolol and telmisartan who also have diabetes

研究概览

简要总结

Hypertension is a leading modifiable risk factor for cardiovascular morbidity and mortality worldwide, accounting for approximately 9.4 million deaths annually and 7 percent of global disability-adjusted life years. In India, the condition is particularly alarming, contributing to nearly 10 percent of all deaths, with prevalence rates ranging from 4–15 percent in urban and 2–8 percent in rural populations. Despite the availability of various antihypertensive agents, many patients require combination therapy for optimal control. Nebivolol, a third-generation beta1-selective blocker, not only reduces blood pressure but also enhances vasodilation via nitric oxide release. Telmisartan, a long-acting angiotensin II receptor blocker (ARB), offers potent and sustained antihypertensive effects with good tissue penetration. Combining these two agents, which have complementary mechanisms of action, may offer superior blood pressure control in patients inadequately managed by monotherapy.

To assess the usage pattern and safety of the fixed-dose combination (FDC) of nebivolol and telmisartan in clinical practice, a retrospective, multicentric data collection study involving approximately 15,000 hypertension patients is planned across various sites in India. Data of  male or female patients aged more than 18 years and patients diagnosed with hypertension and treated with FDC of nebivolol and telmisartan will be collected and analyzed for this study.

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

  • Male or female patients aged more than or equal to 18 years
  • Patients diagnosed with hypertension and treated with FDC of nebivolol and telmisartan.

排除标准

  • 未提供

结局指标

主要结局

1. Proportion of patients with hypertension on FDC of Nebivolol and telmisartan who also have diabetes

时间窗: Baseline

次要结局

  • 1. Proportion of newly diagnosed patients with hypertension on FDC of Nebivolol & telmisartan who also have diabetes(2. Proportion of patients on fixed dose combination of nebivolol & telmisartan experiencing adverse events)

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 Mukesh Gabhane

Torrent Pharmaceuticals Ltd.

研究点 (1)

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