A Clinical Study to observe the effects of combination of Telmisartan and Amelodipine in patients with Uncontrolled Hypertension alone,Or with Type II Diabetes Mellitus
Phase 4
Completed
- Conditions
- Health Condition 1: null- Hypertensive patients at risk of cardiovascular events
- Registration Number
- CTRI/2011/12/002189
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1000
Inclusion Criteria
Uncontrolled hypertensives (BP more than 140/90 despite monotherapy with Telmisartan and Amlodipine
OR
BP more than 130/80 mmHg for hypertensive patients with Diabetes
Exclusion Criteria
Age below 18 years and above 75years
Secondary hypertension
Patients requiring concomitant anti-hypertensive medications other than angiotensin receptor blockers (ARBs) or Amlodipine
Uncontrolled diabetes mellitus
Pregnant women and lactating mothers
Females of child bearing age not practicing contraception or not willing to use barrier contraceptive
Known hypersensitivity to Telmisartan/Amlodipine
Patients with severe and or significant renal, hepatic or cardiac disease
Not willing to provide written informed consent and comply with the protocol
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Magnitude of systolic and diastolic blood pressure reduction from baseline at end of 8 weeks of treatment <br/ ><br>Percent of subjects reaching blood pressure target of 140/90 mmHg in hypertensive patients with uncontrolled hypertension and 130/80mmHg in hypertensive patients with diabetes at end of 8 weeks of treatment <br/ ><br>Timepoint: 8 weeks
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil