A clinical trial to study the effects of two drugs, fixed dose combination capsules of Telmisartan & Indapamide (as sustained release) and Telmisartan tablets in patients with hypertension.
- Conditions
- Health Condition 1: I10- Essential (primary) hypertensionHealth Condition 2: null- Hypertension
- Registration Number
- CTRI/2009/091/000863
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Patients of either sex more than or equal to 18 years of age (No upper age limit was mentioned in our Protocol for this clinical trial).
2.Patients with hypertension (defined as supine systolic and/or diastolic blood pressure more than 140 mm Hg and 90 mm Hg respectively)
3.Informed consent of the patient/relative
1.Pregnancy and/or Lactation
2.Patients with anuria, progressive & severe oliguria, hepatic coma, hypokalaemia, hyponatremia, hypochloremia, volume depletion, hyperuricaemia, secondary hypertension, congestive heart failure, systemic lupus erythematosus.
3.Patients with hepatic and /or renal dysfunction or bilateral renal artery stenosis.
4.Patients with a history of known hypersensitivity to either Telmisartan or Indapamide or to other sulfonamide derivatives or to any other component of the study drugs
5.Patients with any other serious concurrent illness or malignancy
6.Patients with continuing history of alcohol and / or drug abuse
7.Participation in another clinical trial in the past 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The degree of reduction in supine diastolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)Timepoint: 2,4 & 6 weeks
- Secondary Outcome Measures
Name Time Method The degree of reduction in supine systolic blood pressure at the end of the study (week 6) as compared to the baseline (prior to initiation of study medication i.e. week 0)Timepoint: 2,4 & 6 weeks
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