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

This study has been completed.
Sponsor:
Collaborator:
St. John's Research Institute
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00819104
First received: January 7, 2009
Last updated: September 7, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Primary Hypertension
Drug: Metoprolol XL 50mg + Amlodipine 5mg
Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg
Drug: Metoprolol XL 50mg
Drug: Metoprolol XL 25 mg
Drug: Amlodipine 5mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in the heart rate,Number of responders & control rates. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 402
Study Start Date: November 2008
Study Completion Date: August 2009
Arms Assigned Interventions
Experimental: 1
FDC of Metoprolol XL 50mg + Amlodipine 5mg
Drug: Metoprolol XL 50mg + Amlodipine 5mg
tablet,oral,OD,8 weeks
Other Name: 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 Name: Selomax 25/2.5
Active Comparator: 3
Extended release Metoprolol succinate
Drug: Metoprolol XL 50mg
tablet,oral,OD,8 weeks
Other Name: Revelol XL
Active Comparator: 4
Extended release Metoprolol succinate
Drug: Metoprolol XL 25 mg
tablet,oral,OD,8 weeks
Other Name: Revelol XL
Active Comparator: 5
Amlodipine 5mg in immediate release formulation
Drug: Amlodipine 5mg
tablet,oral,OD,8 weeks
Other Name: Amlogard

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819104

Locations
India
Research Site
Hyderabad, Andhra Pradesh, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Karnataka, India
Research Site
Calicut, Kerala, India
Research Site
Mumbai, Maharashtra, India
Research Site
Poona, Maharashtra, India
Research Site
Jaipur, Rajasthan, India
Research Site
Lucknow, Uttar Pradesh, India
Research Site
Kolkata, West Bengal, India
Research Site
Bangalore, India
Research Site
Delhi, India
Sponsors and Collaborators
AstraZeneca
St. John's Research Institute
  More Information

No publications provided

Responsible Party: Dr. Paurus M Irani; VP Medical & Regulatory, AstraZeneca Pharmaceuticals India Ltd.
ClinicalTrials.gov Identifier: NCT00819104     History of Changes
Other Study ID Numbers: D4022L00006
Study First Received: January 7, 2009
Last Updated: September 7, 2009
Health Authority: India: Drugs Controller General of India

Keywords provided by AstraZeneca:
Primary hypertension
Metoprolol XL
Amlodipine

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Metoprolol
Amlodipine
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents

ClinicalTrials.gov processed this record on August 19, 2014