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.

Phase 3

Completed

• Conditions: Secondary hypertension, unspecified,

• Registration Number: CTRI/2010/091/000122
• Lead Sponsor: Vapi Care Pharma Pvt Ltd

Brief Summary

This is a Phase III, Multicenter, Open Label, Single Treatment 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 & Severe Hypertensive Patients. After inclusion of patients in the trial the blood pressure measurement will be done at baseline, and then every 2 weeks till normalisation of blood pressure up to maximum of 12 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-25
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

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

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 Tablet	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 Tablet	12 weeks

Trial Locations

Locations (5)

Life Care Institute of Medical science; 🇮🇳 Ahmadabad, GUJARAT, India

Modi Clinic; 🇮🇳 Ahmadabad, GUJARAT, India

Mukim Medical Nursing Home; 🇮🇳 Ahmadabad, GUJARAT, India

Om Navjivan Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Shuklas Hospital; 🇮🇳 Surat, GUJARAT, India

Life Care Institute of Medical science

🇮🇳Ahmadabad, GUJARAT, India

Dr. Jay Shah

Principal investigator

079-40204020

jayshah08@yahoo.co.in