A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
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: Recruiting
Sponsored by: AstraZeneca Overall contact:
AstraZeneca Pharma India Ltd Clinical Study Information, Phone: +91-80-23622021, Email: sudhanshu.pandey@astrazeneca.com
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: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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
AstraZeneca Pharma India Ltd Clinical Study Information, Phone: +91-80-23622021, Email: sudhanshu.pandey@astrazeneca.com
Research Site, Bangalore, India; Recruiting
Research Site, Delhi, India; Active, not recruiting
Research Site, Hyderabad, Andhra Pradesh, India; Not yet recruiting
Research Site, Ahmedabad, Gujarat, India; Recruiting
Research Site, Bangalore, Karnataka, India; Recruiting
Research Site, Calicut, Kerala, India; Recruiting
Research Site, Mumbai, Maharashtra, India; Recruiting
Research Site, Poona, Maharashtra, India; Not yet recruiting
Research Site, Jaipur, Rajasthan, India; Active, not recruiting
Research Site, Lucknow, Uttar Pradesh, India; Not yet recruiting
Research Site, Kolkata, West Bengal, India; Not yet recruiting
Additional Information
Starting date: November 2008
Ending date: September 2009
Last updated: February 9, 2009
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