A study to compare the efficacy, safety and tolerability of Selomax with its individual components - MARS

Study identifier:D4022L00006

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A five-arm, randomised, open label, multi-centre, prospective study to compare the efficacy, safety and tolerability of Metoprolol XL plus Amlodipine combination (Selomax TM) with Metoprolol XL and Amlodipine as individual components in management of hypertension in Indian patients.

Medical condition

Primary hypertension

Phase

Phase 4

Healthy volunteers

No

Study drug

Metoprolol XL 50mg + Amlodipine 5mg, Metoprolol XL 25 mg + Amlodipine 2.5mg, Metoprolol XL 50mg, Metoprolol XL 25 mg, Amlodipine 5mg

Sex

All

Actual Enrollment

402

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 01 Nov 2008
Primary Completion Date: -
Study Completion Date: 01 Aug 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Sept 2009 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

St.John's Clinical Research Institute, Bangalore, India

Inclusion and exclusion criteria