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

Sponsors and Collaborators:	AstraZeneca St.John's Clinical Research Institute, Bangalore, India
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00819104

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 IV

MedlinePlus related topics: High Blood Pressure

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	360
Study Start Date:	November 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental FDC of Metoprolol XL 50mg + Amlodipine 5mg	Drug: Metoprolol XL 50mg + Amlodipine 5mg tablet,oral,OD,8 weeks
2: Experimental FDC of Metoprolol XL 25mg + Amlodipine 2.5mg	Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg tablet,oral,OD,8 weeks
3: Active Comparator Extended release Metoprolol succinate	Drug: Metoprolol XL 50mg tablet,oral,OD,8 weeks
4: Active Comparator Extended release Metoprolol succinate	Drug: Metoprolol XL 25 mg tablet,oral,OD,8 weeks
5: Active Comparator Amlodipine 5mg in immediate release formulation	Drug: Amlodipine 5mg tablet,oral,OD,8 weeks

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

Contacts

Contact: AstraZeneca Pharma India Ltd Clinical Study Information	+91-80-23622021	sudhanshu.pandey@astrazeneca.com
Contact: Denis Xavier	+91-80-2552 6382	denis@iphcr.res.in

Locations

India
Research Site	Recruiting
Bangalore, India
Research Site	Active, not recruiting
Delhi, India
India, Andhra Pradesh
Research Site	Not yet recruiting
Hyderabad, Andhra Pradesh, India
India, Gujarat
Research Site	Recruiting
Ahmedabad, Gujarat, India
India, Karnataka
Research Site	Recruiting
Bangalore, Karnataka, India
India, Kerala
Research Site	Recruiting
Calicut, Kerala, India
India, Maharashtra
Research Site	Recruiting
Mumbai, Maharashtra, India
Research Site	Not yet recruiting
Poona, Maharashtra, India
India, Rajasthan
Research Site	Active, not recruiting
Jaipur, Rajasthan, India
India, Uttar Pradesh
Research Site	Not yet recruiting
Lucknow, Uttar Pradesh, India
India, West Bengal
Research Site	Not yet recruiting
Kolkata, West Bengal, India

Sponsors and Collaborators

AstraZeneca

St.John's Clinical Research Institute, Bangalore, India

More Information

Responsible Party:	AstraZeneca Pharmaceuticals India Ltd. ( Dr. Paurus M Irani; VP Medical & Regulatory )
Study ID Numbers:	D4022L00006
Study First Received:	January 7, 2009
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00819104
Health Authority:	India: Drugs Controller General of India

Keywords provided by AstraZeneca:

Primary hypertension
Metoprolol XL
Amlodipine

Study placed in the following topic categories:

Calcium, Dietary
Metoprolol succinate
Vascular Diseases
Essential hypertension

Metoprolol
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Sympatholytics
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Membrane Transport Modulators
Autonomic Agents
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Peripheral Nervous System Agents
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009