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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Hypertension

Intervention: 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 (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

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.

Clinical Details

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

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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.

Locations and Contacts

Research Site, Bangalore, India

Research Site, Delhi, 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

Additional Information

Starting date: November 2008
Last updated: September 7, 2009

Page last updated: August 23, 2015

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