In India, Bisoprolol and Telmisartan are already approved and marketed. Therefore, considering the unmet need for an FDC and based on regulatory requirement M/s. Windlas Biotech Ltd. proposes the present study be conducted to generate data on the Indian population.The study design is a multi-centre study to evaluate efficacy and safety of fixed-dose combination (FDC) of Bisoprolol 5 mg and Telmisartan 40 mg tablet in subjects with mild to moderate hypertension. The purpose of the present study is to demonstrate that a fixed-dose combination (FDC) of Bisoprolol 5 mg and Telmisartan 40 mg tablet is efficacious and safe in Indian subjects with regard to the routine clinical setting.

This will be a multicentre, randomized, double-blind, parallel-Group, comparative active-controlled phase III clinical trial to evaluate the efficacy and safety of fixed-Dose Combination of Bisoprolol 5 mg and Telmisartan 40 mg tablet versus a fixed-Dose combination of Metoprolol Succinate ER 50 mg and Telmisartan 40 mg tablets in subjects with mild to moderate hypertension. Initially, subjects will be screened as per predefined eligibility criteria for the study. The ITT population will include approximately a total number of 264 eligible male and female patients of any ethnicity diagnosed with mild to moderate hypertension. Eligible 264 subjects will be either enrolled to receive Fixed-Dose Combination (FDC) of Bisoprolol 5 mg and Telmisartan 40 mg tablet or Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Telmisartan 40 mg tablets in 1:1 ratio.

Test Arm: Treatment Arm 1: Fixed-Dose Combination (FDC) of Bisoprolol 5 mg and Telmisartan 40 mg tablet (n=132)

 Reference Arm: Treatment Arm 2: Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and Telmisartan 40 mg (n=132)

Efficacy:

Primary endpoint

·                           Percentage of the subjects achieved the target levels of clinical BP among mild to moderate hypertensive subjects (target level: SBP < 140 mm Hg and DBP < 90 mm Hg);

Secondary end point

·                      Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline (After 4, 8 and 12 weeks)

·                      Proportion of responders after 12 weeks of dosing (Responder rate defined as the proportion of subjects with a decrease in diastolic BP by at least 10 mmHg).

·                      Reduction in mean heart rate compared to baseline (After 4, 8 and 12 weeks)

Safety (Screening visit to end of study visit)

·                           Adverse Events (AE) assessment

·                           Physical & systemic examination

·                           Vital signs

.                 Lab abnormalities