A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components

Phase 4

Completed

• Conditions: Hypertension

• Registration Number: CTRI/2008/091/000190
• Lead Sponsor: AstraZeneca

Brief Summary

This is a randomised, open-label; parallel group, multicentric study comparing the efficacy and safety of fixed-dose-combinations of Metoprolol XL plus Amlodipine with individual components of the combination. SelomaxTM50/5 will also be compared with SelomaxTM 25/2.5 in lowering of BP (SBP and DBP) in Indian patients with essential hypertension.Male and female patients of essential hypertension aged between 18-80 years will be studied. The patients should not have a history of prior cardiovascular disease. The outcomes are BP lowering and the tolerability of the fixed dose combinations compared to the individual comparators.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-11
• Study Completion: 2009-07-31
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 402

Inclusion Criteria

Ages Eligible for Study: 18 Years to 80 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Patients of hypertension (primary) , as judged by 2 BP measurements before randomisation Those who have given their written consent for the study.

Exclusion Criteria

• Patients of other forms of hypertension (other than primary) Those who have consistently BP > /=180/120mmHg Patients with a prior history of chest pain, heart attacks, conduction defects and strokes.
• Patients of diabetes requiring insulin,asthma and kidney diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in BP with Selomax? 50/5 at the end of the randomisation treatment period.	Time Frame: 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period	Time Frame: 8 weeks
Change in the heart rate,Number of responders & control rates	Time Frame: 8 weeks
Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin	8 weeks, Safety issue

Trial Locations

Locations (8)

Baby Memorial Hospital; 🇮🇳 Kozhikode, KERALA, India

Fortis Escorts Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Health and Harmony; 🇮🇳 Mumbai, MAHARASHTRA, India

Lifecare Institute Of Medical Sciences & Research; 🇮🇳 Ahmadabad, GUJARAT, India

Mahavir Jain Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

National Heart Institute; 🇮🇳 Delhi, DELHI, India

Poona Hospital & Reserch Centre; 🇮🇳 Pune, MAHARASHTRA, India

St Johns Medical Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Baby Memorial Hospital

🇮🇳Kozhikode, KERALA, India

Dr Ashokan Nambiar

Principal investigator

info@babymhospital.org