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

Primary Hypertension Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819104
• Other study ID #: D4022L00006
• Status: Completed
• Phase: Phase 4
• First received: January 7, 2009
• Last updated: September 7, 2009
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Primary Hypertension

Intervention

Drug:
• Metoprolol XL 50mg + Amlodipine 5mg
tablet,oral,OD,8 weeks
• Metoprolol XL 25 mg + Amlodipine 2.5mg
tablet,oral,OD,8 weeks
• Metoprolol XL 50mg
tablet,oral,OD,8 weeks
• Metoprolol XL 25 mg
tablet,oral,OD,8 weeks
• Amlodipine 5mg
tablet,oral,OD,8 weeks

Locations

Country	Name	City	State
India	Research Site	Ahmedabad	Gujarat
India	Research Site	Bangalore	Karnataka
India	Research Site	Bangalore
India	Research Site	Calicut	Kerala
India	Research Site	Delhi
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Jaipur	Rajasthan
India	Research Site	Kolkata	West Bengal
India	Research Site	Lucknow	Uttar Pradesh
India	Research Site	Mumbai	Maharashtra
India	Research Site	Poona	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	St. John's Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.		8 weeks	No
Secondary	Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period.		8 weeks	No
Secondary	Change in the heart rate,Number of responders & control rates.		8 weeks	No
Secondary	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		8 weeks	Yes