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.
Overview
- Phase
- Phase 4
- Intervention
- Metoprolol XL 50mg + Amlodipine 5mg
- Conditions
- Primary Hypertension
- Sponsor
- AstraZeneca
- Enrollment
- 402
- Locations
- 1
- Primary Endpoint
- Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
1
FDC of Metoprolol XL 50mg + Amlodipine 5mg
Intervention: Metoprolol XL 50mg + Amlodipine 5mg
2
FDC of Metoprolol XL 25mg + Amlodipine 2.5mg
Intervention: Metoprolol XL 25 mg + Amlodipine 2.5mg
3
Extended release Metoprolol succinate
Intervention: Metoprolol XL 50mg
4
Extended release Metoprolol succinate
Intervention: Metoprolol XL 25 mg
5
Amlodipine 5mg in immediate release formulation
Intervention: Amlodipine 5mg
Outcomes
Primary Outcomes
Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period.
Time Frame: 8 weeks
Secondary Outcomes
- 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)