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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Primary Hypertension

Treatments: Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg; Drug: Metoprolol XL 50mg + Amlodipine 5mg; Drug: Metoprolol XL 25 mg; Drug: Amlodipine 5mg; Drug: Metoprolol XL 50mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00819104

D4022L00006

Details and patient eligibility

About

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.

Enrollment: 402 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

402 participants in 5 patient groups

1

Experimental group

Description:

FDC of Metoprolol XL 50mg + Amlodipine 5mg

Treatment:

Drug: Metoprolol XL 50mg + Amlodipine 5mg

2

Experimental group

Description:

FDC of Metoprolol XL 25mg + Amlodipine 2.5mg

Treatment:

Drug: Metoprolol XL 25 mg + Amlodipine 2.5mg

3

Active Comparator group

Description:

Extended release Metoprolol succinate

Treatment:

Drug: Metoprolol XL 50mg

4

Active Comparator group

Description:

Extended release Metoprolol succinate

Treatment:

Drug: Metoprolol XL 25 mg

5

Active Comparator group

Description:

Amlodipine 5mg in immediate release formulation

Treatment:

Drug: Amlodipine 5mg