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

September 7, 2009 updated by: AstraZeneca

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India
        • Research Site
      • Delhi, India
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
    • Kerala
      • Calicut, Kerala, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Poona, Maharashtra, India
        • Research Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Research Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India
        • Research Site
    • West Bengal
      • Kolkata, West Bengal, India
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
FDC of Metoprolol XL 50mg + Amlodipine 5mg
Drug: Metoprolol XL 50mg + Amlodipine 5mg
tablet,oral,OD,8 weeks
Other Names:
  • 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 Names:
  • Selomax 25/2.5
Active Comparator: 3
Extended release Metoprolol succinate
Drug: Metoprolol XL 50mg
tablet,oral,OD,8 weeks
Other Names:
  • Revelol XL
Active Comparator: 4
Extended release Metoprolol succinate
Drug: Metoprolol XL 25 mg
tablet,oral,OD,8 weeks
Other Names:
  • Revelol XL
Active Comparator: 5
Amlodipine 5mg in immediate release formulation
Drug: Amlodipine 5mg
tablet,oral,OD,8 weeks
Other Names:
  • Amlogard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.
Time Frame: 8 weeks
8 weeks
Change in the heart rate,Number of responders & control rates.
Time Frame: 8 weeks
8 weeks
Incidence of adverse events (serious and non-serious) in each arm.Change in hemogram, serum chemistry (Liver function tests (LFT), Renal function tests (RFT), plasma lipids, Blood Glucose, HbA1c), and Ur.albumin
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

St. John's Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

January 7, 2009

First Submitted That Met QC Criteria

January 7, 2009

First Posted (Estimate)

January 8, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2009

Last Update Submitted That Met QC Criteria

September 7, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D4022L00006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Hypertension

Clinical Trials on Metoprolol XL 50mg + Amlodipine 5mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe