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

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Metoprolol Metoprolol tartrate Amlodipine Metoprolol succinate Amlodipine besylate Metoprolol fumarate

U.S. FDA Resources

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

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 May 22, 2013

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