Comparison of Olmesartan +Amlodipine +Hydrochlorothiazide combination with Olmesartan +Hydrochlorothiazide combination in essential hypertension.
Phase 3
Completed
- Registration Number
- CTRI/2010/091/006071
- Lead Sponsor
- Aristo Pharmaceuticals Pvt. Ltd. 23-Off veera desai road, Andheri W Mumbai-400053
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
patients >18 yrs with mild to moderate uncomplicated essential hypertension, patients with mean sitting systolic BP 140-200 mmHg and mean sitting diastolic BP 90-120 mmHg. patients with written informed consent and should be on single antihypertensive drug, etc.
Exclusion Criteria
Pregnant and lactating women, patients with mean sitting systolic BP >200 mmHg and mean sitting diastolic BP >120 mmHg. suspected secondary hypertension, history of MI, stroke, TIA, other Cv events in last 6 months, patients with uncorrected volume or sodium depletion, etc.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in arterial blood pressureTimepoint: Twelve weeks therapy
- Secondary Outcome Measures
Name Time Method Safety of FDCTimepoint: Twelve week therapy