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.

Phase 3

Completed

• Conditions: Essential (primary) hypertension, Hypertension,

• Registration Number: CTRI/2009/091/000863
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination capsules of Telmisartan & Indapamide (as sustained release) and Telmisartan tablets given once a day for 6 weeks in 200 patients with hypertension that will be conducted in India. The primary outcome measures will be the degree of reduction in supine diastolic blood pressure at the end of the study as compared to the baseline.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 2018-10-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)	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)	2,4 & 6 weeks

Trial Locations

Locations (6)

B. L. Nair Hospital & T. N. Medical College, Mumbai; 🇮🇳 Mumbai, MAHARASHTRA, India

Gandhi Medical College & Associated Hospital, Bhopal; 🇮🇳 Bhopal, MADHYA PRADESH, India

Kakadiya Hospital, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Mayur Hospital & Research Centre, Indore; 🇮🇳 Indore, MADHYA PRADESH, India

Shashwat Hospital & Research Centre, Ahmedabad; 🇮🇳 Ahmadabad, GUJARAT, India

Shivam Clinic, Vadodara; 🇮🇳 Vadodara, GUJARAT, India

B. L. Nair Hospital & T. N. Medical College, Mumbai

🇮🇳Mumbai, MAHARASHTRA, India

Dr G C Rajadhyaksha

Principal investigator

9821695349

girishraj63@hotmail.com