Clinical trial of S-Metoprolol and Telmisartan combination tablet in the treatment of hypertensio
- Conditions
- Health Condition 1: null- Patients with essential hypertension
- Registration Number
- CTRI/2011/06/001819
- Lead Sponsor
- Emcure Pharmaceuticals Ltd Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- 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 weeksTimepoint: 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 Compliance to treatmentTimepoint: After 4, 8 and 12 weeks;Mean reduction in systolic and diastolic blood pressure measured in sitting position compared to baselineTimepoint: After 4, 8 and 12 weeks;Percent of the subjects experiencing any drug related adverse event as evaluated and recorded by the investigatorTimepoint: After 4, 8 and 12 weeks;Reduction in mean heart rate compared to baselineTimepoint: After 4, 8 and 12 weeks;Subjectâ??s as well as Physicians global assessment about the tolerability of the drug <br/ ><br>Timepoint: After 12 weeks