A clinical study to evaluate the safety and efficacy of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg tablet in mild, moderate and severe hypertensive patients.
- Conditions
- Health Condition 1: I159- Secondary hypertension, unspecified
- Registration Number
- CTRI/2010/091/000122
- Lead Sponsor
- Vapi Care Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Written informed consent from the patient.
-Male and female patients with age above 18 years inclusive.
-Diagnosis of mild, moderate & severe hypertensive patients with or without concomitant diabetes.
-Patients who will be uncontrolled on monotherapy with or without diabetes mellitus will be included in this study.
-Patients with any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
-Known or suspected secondary hypertension.
-Patient with history of asthma or angina.
-Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
-Known hypersensitivity to Telmisartan, Amlodipine and Hydrochlorthiazide.
-Patient who is consuming/ has received drugs, which have interaction with Telmisartan, Amlodipine and Hydrochlorthiazide, during last 14 days.
-Participation in any other clinical trial during last 30 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in blood pressure for FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg TabletTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Percentage of patients with significant reduction in blood pressure of FDC of Telmisartan 80/40/20mg + Amlodipine 10/5/2.5mg + Hydrochlorthiazide 25/12.5/12.5mg TabletTimepoint: 12 weeks