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

Primary Purpose

Primary Hypertension

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Metoprolol XL 50mg + Amlodipine 5mg
Metoprolol XL 25 mg + Amlodipine 2.5mg
Metoprolol XL 50mg
Metoprolol XL 25 mg
Amlodipine 5mg
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hypertension focused on measuring Primary hypertension, Metoprolol XL, Amlodipine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

FDC of Metoprolol XL 50mg + Amlodipine 5mg

FDC of Metoprolol XL 25mg + Amlodipine 2.5mg

Extended release Metoprolol succinate

Extended release Metoprolol succinate

Amlodipine 5mg in immediate release formulation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 7, 2009
Last Updated
September 7, 2009
Sponsor
AstraZeneca
Collaborators
St. John's Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00819104
Brief Title
A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
Acronym
MARS
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
St. John's Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hypertension
Keywords
Primary hypertension, Metoprolol XL, Amlodipine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
FDC of Metoprolol XL 50mg + Amlodipine 5mg
Arm Title
2
Arm Type
Experimental
Arm Description
FDC of Metoprolol XL 25mg + Amlodipine 2.5mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
Extended release Metoprolol succinate
Arm Title
4
Arm Type
Active Comparator
Arm Description
Extended release Metoprolol succinate
Arm Title
5
Arm Type
Active Comparator
Arm Description
Amlodipine 5mg in immediate release formulation
Intervention Type
Drug
Intervention Name(s)
Metoprolol XL 50mg + Amlodipine 5mg
Other Intervention Name(s)
Selomax 50/5
Intervention Description
tablet,oral,OD,8 weeks
Intervention Type
Drug
Intervention Name(s)
Metoprolol XL 25 mg + Amlodipine 2.5mg
Other Intervention Name(s)
Selomax 25/2.5
Intervention Description
tablet,oral,OD,8 weeks
Intervention Type
Drug
Intervention Name(s)
Metoprolol XL 50mg
Other Intervention Name(s)
Revelol XL
Intervention Description
tablet,oral,OD,8 weeks
Intervention Type
Drug
Intervention Name(s)
Metoprolol XL 25 mg
Other Intervention Name(s)
Revelol XL
Intervention Description
tablet,oral,OD,8 weeks
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5mg
Other Intervention Name(s)
Amlogard
Intervention Description
tablet,oral,OD,8 weeks
Primary Outcome Measure Information:
Title
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.
Time Frame
8 weeks
Title
Change in the heart rate,Number of responders & control rates.
Time Frame
8 weeks
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Calicut
State/Province
Kerala
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Poona
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Jaipur
State/Province
Rajasthan
Country
India
Facility Name
Research Site
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Research Site
City
Kolkata
State/Province
West Bengal
Country
India
Facility Name
Research Site
City
Bangalore
Country
India
Facility Name
Research Site
City
Delhi
Country
India

12. IPD Sharing Statement

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

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