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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: St. John's Research Institute
• Treatments: Amlodipine; Metoprolol

Criteria

Inclusion Criteria:

• 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.