Clinical trial of S-Metoprolol and Telmisartan combination tablet in the treatment of hypertension
- Conditions
- Patients with essential hypertension
- Registration Number
- CTRI/2011/06/001819
- Lead Sponsor
- Emcure Pharmaceuticals Ltd Pune
- Brief Summary
This multicentric, open label, comparative clinical trial is planned to assess efficacy and safety of FDC of S(-) Metoprolol(25 mg) and Telmisartan(20/40 mg) Tablet. Patients stisfing Patient satisfying inclusion and exclusion criteria will receive either Test / Reference drug as per randomization..In Test group patient will receive FDC of S-Metoprolol 25 mg + Telmisartan 20mg and Reference group will receive one tablet of Metoprolol 50mg and Telmisartan 20 mg each. In test group dose will modified in subsequent visit to S-Metoprolol 25mg and Telmisartan 40 mg and in Reference group it will modify upto Metoprolo 50 mg and Olmesartan 40 mg each. (if BP > 140/90). Baseline laboratory investigations will be done. Patients will be evaluated for efficacy and safety variables after 4, 8 and 12 weeks of therapy. Same laboratory investigations will be repeated after 12 weeks of therapy except ECG. The study duration is of 12 weeks
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Male or female patients between 18-65 years of age, Patients diagnosed with essential hypertension not controlled on monotherapy or newly diagnosed Stage II hypertensives, Patients willing to give written informed consent and willing to comply with study protocol.
Patients previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or angiotensin receptor blockers, Patients with history of secondary or malignant hypertension, Patients with evidence of any cardiac arrhythmia on ECG, Patients with known significant respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception, Patients 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, Patients with known alcohol or drug abuse, Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks Responder rate defined as proportion of patients with decrease in diastolic BP by at least 10 mmHg compared to baseline after 12 weeks
- Secondary Outcome Measures
Name Time Method Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baseline After 4, 8 and 12 weeks Reduction in mean heart rate compared to baseline After 4, 8 and 12 weeks Compliance to treatment After 4, 8 and 12 weeks Subject’s as well as Physicians global assessment about the tolerability of the drug Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigator After 4, 8 and 12 weeks
Trial Locations
- Locations (16)
Abhinav Multispeciality Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Chest Research Centre
🇮🇳Chennai, TAMIL NADU, India
Dande Diabetes and Heart care Centre, Maternity Home
🇮🇳Aurangabad, MAHARASHTRA, India
Dhanvantari Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Gaikwads Critical Care Centre
🇮🇳Nagpur, MAHARASHTRA, India
Giridhar Clinic
🇮🇳Pune, MAHARASHTRA, India
Ketki Hospital
🇮🇳Aurangabad, MAHARASHTRA, India
Kranti Cardiac Centre
🇮🇳Sangli, MAHARASHTRA, India
Medicine Research & Diagnostic Pvt. Ltd.
🇮🇳Kolkata, WEST BENGAL, India
Nightingale Hospital
🇮🇳Kolkata, WEST BENGAL, India
Scroll for more (6 remaining)Abhinav Multispeciality Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaDr Sudhir Bhatnagar MDMedPrincipal investigatordrsudhirbhatnagar@gmail.com