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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00819104
Acronym
MARS
Enrollment
402
Registered
2009-01-08
Start date
2008-11-30
Completion date
2009-08-31
Last updated
2009-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Hypertension

Keywords

Primary hypertension, Metoprolol XL, Amlodipine

Brief 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.

Interventions

DRUGMetoprolol XL 50mg + Amlodipine 5mg

tablet,oral,OD,8 weeks

DRUGMetoprolol XL 25 mg + Amlodipine 2.5mg

tablet,oral,OD,8 weeks

DRUGMetoprolol XL 50mg

tablet,oral,OD,8 weeks

DRUGMetoprolol XL 25 mg

tablet,oral,OD,8 weeks

DRUGAmlodipine 5mg

tablet,oral,OD,8 weeks

Sponsors

St. John's Research Institute
CollaboratorOTHER
AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.8 weeks

Secondary

MeasureTime frame
Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.8 weeks
Change in the heart rate,Number of responders & control rates.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.albumin8 weeks

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026