A clinical study to evaluate the effects of Fixed Dose Combination of 2 drugs, Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) in patients with high blood pressure
- Conditions
- Health Condition 1: null- Stage II/ III hypertension
- Registration Number
- CTRI/2010/091/000114
- Lead Sponsor
- Serdia Pharmaceuticals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 240
1.Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mmHg) OR
2.Uncontrolled patients of hypertension with a baseline blood pressure > 140/90 mmHg on monotherapy with a Calcium Channel Blocker (CCB)
3.Patients of either sex
4.With confirmed diagnosis of Stage II/ III (moderate to severe) hypertension, as per JNC 7 guidelines
1)Uncontrolled diabetes
2)H/o myocardial infarction within the previous 3 months
3)H/o cerebrovascular event within previous 3 months
4)Uncontrolled arrhythmias
5)H/o Heart failure
6)Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders
7)Patients unwilling to give informed consent.
8)Patients with history of hypersensitivity to Indapamide or Amlodipine
9)Any contraindication to Thiazide type diuretic and/or CCB
10)Pregnancy or lactation
11)Patients with any other condition or disease, which in opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant.
12)Patients previously enrolled in similar trial in the last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the blood pressure reduction rates in moderate to severe hypertensive patients after treatment with an FDC (Indapamide S.R. 1.5 mg + Amlodipine 5 mg) given once daily in the morning during the study evaluation periodTimepoint: Day 0, Day 15, Day 30 & Day 45
- Secondary Outcome Measures
Name Time Method To access the safety and tolerability of Indapamide S.R. 1.5 mg + Amlodipine 5 mgTimepoint: Day 0, Day 15, Day 30 & Day 45