A Study to Compare the Efficacy, Safety and Tolerability of Selomax With Its Individual Components
Phase 4
Completed
- Conditions
- Primary Hypertension
- Interventions
- Registration Number
- NCT00819104
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Metoprolol XL 25 mg Extended release Metoprolol succinate 1 Metoprolol XL 50mg + Amlodipine 5mg FDC of Metoprolol XL 50mg + Amlodipine 5mg 2 Metoprolol XL 25 mg + Amlodipine 2.5mg FDC of Metoprolol XL 25mg + Amlodipine 2.5mg 3 Metoprolol XL 50mg Extended release Metoprolol succinate 5 Amlodipine 5mg Amlodipine 5mg in immediate release formulation
- Primary Outcome Measures
Name Time Method Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period. 8 weeks
- Secondary Outcome Measures
Name Time Method Change in BP (SBP,DBP & mean BP) with SelomaxTM 25/2.5 at the end of the randomisation period. 8 weeks Change in the heart rate,Number of responders & control rates. 8 weeks 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
Trial Locations
- Locations (1)
Research Site
🇮🇳Delhi, India