Effectiveness and Safety of the Telmisartan and Amlodipine Fixed-dose Combination in Managing Hypertension among Indian Patients (TACT India Study): Rationale and Study Design.

Background: The prevalence of hypertension is on the rise, with approximately 200 million individuals affected by this condition in India. Epidemiological studies suggest that one in every three adults in India has hypertension. Fixed-dose combinations (FDCs) present a potential strategy to address the challenge of effective blood pressure control. They are now recommended for the initiation in most hypertensive patients by the guidelines. However, studies evaluating the safety and effectiveness of FDCs in large Indian populations with hypertension are few. Aim: The aim of this real-world study is to evaluate the safety and effectiveness of the fixed-dose combination of telmisartan and amlodipine in managing hypertension in Indian patients. Materials and methods: This prospective, multicenter, observational, real-world evidence study is designed to enroll 10,000 eligible participants from 1,000 study sites across India. Adult patients with newly diagnosed or uncontrolled hypertension on monotherapy would be eligible for enrollment in the study. The study participants would be administered the study treatment per the treating physician's routine clinical practice and followed up after 8 weeks. The primary endpoint is to measure the change in systolic blood pressure (SBP) from baseline to week 8, while secondary endpoints include determining the percentage of patients who reach their blood pressure targets., description of demographic characteristics of the Indian hypertensive population, and reporting of safety outcomes. Conclusion: The TACT India study will provide longitudinal, real-world data on the effectiveness and safety of telmisartan and amlodipine FDC among a large cohort of the Indian population with hypertension.