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

NCT00819104 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2009-09-09

No results posted yet for this study

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

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

Sponsors & Collaborators

  • St. John's Research Institute

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Completion
2009-08-31

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00819104 on ClinicalTrials.gov