Health Condition 1: I10- Essential (primary) hypertension
Conditions
Interventions
Intervention1: Fixed-Dose Combination of Bisoprolol 5 mg and Telmisartan 40 mg tablet: One tablet daily for 84 days
Control Intervention1: Fixed-Dose Combination of Metoprolol Succinate ER 50 mg and T
Sponsors
Windlas Biotech Limited
Windlas Biotech Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female participants with age 18 years to 60 years (both inclusive) at the time of screening 2. Adult subjects who are capable of understanding and giving written informed consent and willing to comply with the study protocol 3. Subjects diagnosed with mild to moderate Essential Hypertension with SBP ranging between 140-159 mmHg and/or DBP ranging between 90- 99mmHg 4. Females of non-child bearing potential (surgically sterile or menopausal) OR females of child bearing potential using effective birth control measures and non-pregnant & non-lactating females.
Exclusion criteria
Exclusion criteria: 1. Subjects previously sensitive to any of the ingredients of the fixed-dose combination under study or beta-blockers or angiotensin receptor blockers, 2. Subjects with clinically significant renal (estimated glomerular filtration rate: 3. Subjects with hepatocellular insufficiency and in subjects with hepatic failure or active liver disease. 4. Subjects with a known history of secondary or malignant hypertension, severe diastolic hypertension (seated diastolic BP: >114 mm Hg) 5. Subjects with evidence of any cardiac arrhythmia on ECG 6. Any known cardiac disease/disorder in which any of the study medication is contra-indicated (e.g. severe bradycardia, heart block greater than a first degree or significant first-degree block, cardiogenic shock,decompensated cardiac failure, sick sinus syndrome without pacemaker etc.) 7. Subjects with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, 8. Pregnant and lactating women or the women of child bearing age who are not practising the effective means of contraception, 9. Subjects otherwise judged to be inappropriate for inclusion in the study by the investigatorââ?¬•s judgment 10. Subjects who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug, 11. Subjects with known alcohol or drug abuse 12. Subjects with known history of HIV, Hepatitis B and Hepatitis C
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of the subjects achieved the target levels of clinical BP among mild to moderate hypertensive subjects (target level: SBP less than 140 mm Hg and DBP less than 90 mm Hg)Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events assessment, Physical and systemic examination, Vital signs, Lab abnormalitiesTimepoint: 4, 8 and 12 weeks;Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baselineTimepoint: 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).Timepoint: 12 weeks;Reduction in mean heart rate compared to baselineTimepoint: 4, 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr R M Chhabra
Insignia Clinical Services Pvt. Ltd.
Outcome results
None listed