Drug utilization pattern and tolerability of Nebivolol-Telmisartan combination in Indian Hypertensive Patients: A retrospective cross-sectional study (INTEL-HT)
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
Dr Mukesh Gabhane
Torrent Pharmaceuticals Ltd.
