A Clinical Trial to evaluate the efficacy and safety of Bisoprolol and Telmisartan Fixed Dose Combination Tablets for management of Hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertension
- Registration Number
- CTRI/2022/01/039787
- Lead Sponsor
- Windlas Biotech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 292
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.
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: <30 mL/min per 1.73 m2) metabolic, hepatic, or psychiatric disorders
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method