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Completed

NCT Number: NCT00819104

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

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.

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Key information

Conditions

Primary Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Hyderabad, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metoprolol XL 50mg + Amlodipine 5mg

Drug

tablet,oral,OD,8 weeks

Other names: Selomax 50/5

Metoprolol XL 25 mg + Amlodipine 2.5mg

Drug

tablet,oral,OD,8 weeks

Other names: Selomax 25/2.5

Metoprolol XL 50mg

Drug

tablet,oral,OD,8 weeks

Other names: Revelol XL

Metoprolol XL 25 mg

Drug

tablet,oral,OD,8 weeks

Other names: Revelol XL

Amlodipine 5mg

Drug

tablet,oral,OD,8 weeks

Other names: Amlogard

Primary outcomes

  1. Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.

    Time frame: 8 weeks

Secondary outcomes

  1. Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.

    Time frame: 8 weeks

  2. Change in the heart rate,Number of responders & control rates.

    Time frame: 8 weeks

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • St. John's Research Institute

Registry information

Official study 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.

Acronym: MARS

Important dates

Study start
2008
Study completion
2009
First posted
Jan 8, 2009
Registry last updated
Sep 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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