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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Primary Hypertension

Intervention / Treatment
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* Drug: 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>FDC of Metoprolol XL 50mg + Amlodipine 5mg | Drug: Metoprolol XL 50mg + Amlodipine 5mg<br>* tablet,oral,OD,8 weeks<br>* Other names: Selomax 50/5;|
| Experimental: 2<br>FDC of Metoprolol XL 25mg + Amlodipine 2.5mg | Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg<br>* tablet,oral,OD,8 weeks<br>* Other names: Selomax 25/2.5;|
| Active Comparator: 3<br>Extended release Metoprolol succinate | Drug: Metoprolol XL 50mg<br>* tablet,oral,OD,8 weeks<br>* Other names: Revelol XL;|
| Active Comparator: 4<br>Extended release Metoprolol succinate | Drug: Metoprolol XL 25 mg<br>* tablet,oral,OD,8 weeks<br>* Other names: Revelol XL;|
| Active Comparator: 5<br>Amlodipine 5mg in immediate release formulation | Drug: Amlodipine 5mg<br>* tablet,oral,OD,8 weeks<br>* Other names: Amlogard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BP with Selomax™ 50/5 at the end of the randomisation treatment period. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary hypertension, Metoprolol XL, Amlodipine