To assess the Efficacy and tolerability of Bisoprolol in patients with newly diagnosed Stage I essential hypertension.
Phase 4
Completed
- Registration Number
- CTRI/2010/091/000632
- Lead Sponsor
- Merck Serono Merck Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2000
Inclusion Criteria
1 Newly diagnosed JNC 7 Stage I essential hypertension
2 Patient advised CONCOR (Bisoprolol)
3 No other clinically significant co-morbidities
Exclusion Criteria
1 Any contraindications to CONCOR
2 Uncontrolled diabetes (Any ongoing symptoms or complication related to Diabetes)
3 Females in childbearing age not willing to use a reliable mean of contraception
4 Confirmed diagnosis of any CVD except Hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients achieving BP < 140/ 90 mm HgTimepoint: At the end of 12 weeks(responder).
- Secondary Outcome Measures
Name Time Method (1) Average reduction in systolic and diastolic BP. (2) Average time to reach target BP (in responders). (3) Average dose required to control (in responders). (4) Average reduction in Heart Rate. (5) Assessment of compliance at 12 weeks (pill count). (6) Blood Glucose parameters. (7) Renal parameter statusTimepoint: At the end of 12 weeks(responder).