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
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 FDC of Metoprolol XL 50mg + Amlodipine 5mg | Drug: Metoprolol XL 50mg + Amlodipine 5mg tablet,oral,OD,8 weeks Other Name: Selomax 50/5 |
| Experimental: 2 FDC of Metoprolol XL 25mg + Amlodipine 2.5mg | Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg tablet,oral,OD,8 weeks Other Name: Selomax 25/2.5 |
| Active Comparator: 3 Extended release Metoprolol succinate | Drug: Metoprolol XL 50mg tablet,oral,OD,8 weeks Other Name: Revelol XL |
| Active Comparator: 4 Extended release Metoprolol succinate | Drug: Metoprolol XL 25 mg tablet,oral,OD,8 weeks Other Name: Revelol XL |
| Active Comparator: 5 Amlodipine 5mg in immediate release formulation | Drug: Amlodipine 5mg tablet,oral,OD,8 weeks Other Name: Amlogard |
