NCT00819104

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

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 402 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Hypertension

Interventions

Type	Name	Description
DRUG	Metoprolol XL 50mg + Amlodipine 5mg	tablet,oral,OD,8 weeks
DRUG	Metoprolol XL 25 mg + Amlodipine 2.5mg	tablet,oral,OD,8 weeks
DRUG	Metoprolol XL 50mg	tablet,oral,OD,8 weeks
DRUG	Metoprolol XL 25 mg	tablet,oral,OD,8 weeks
DRUG	Amlodipine 5mg	tablet,oral,OD,8 weeks

Timeline

• Start date: 2008-11-01
• Completion: 2009-08-01
• First posted: 2009-01-08
• Last updated: 2009-09-09

Locations

11 sites across 1 country: India