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Clinical Trials/CTRI/2025/08/093314
CTRI/2025/08/093314Not yet recruitingNot Applicable

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

Torrent Pharmaceuticals Ltd.1 site in 1 country15,000 target enrollmentStarted: September 1, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
15,000
Locations
1
Primary Endpoint
1. Proportion of patients with hypertension on FDC of Nebivolol and telmisartan who also have diabetes

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: Baseline

Secondary Outcomes

  • 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)

Investigators

Sponsor
Torrent Pharmaceuticals Ltd.
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Mukesh Gabhane

Torrent Pharmaceuticals Ltd.

Study Sites (1)

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