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

Phase 4CompletedNCT00819104

AstraZeneca402 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

402

Conditions

Primary Hypertension

Interventions

Metoprolol XL 50mg + Amlodipine 5mgDRUG

tablet,oral,OD,8 weeks

Metoprolol XL 25 mg + Amlodipine 2.5mgDRUG

tablet,oral,OD,8 weeks

Metoprolol XL 50mgDRUG

tablet,oral,OD,8 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (11)

Research Site

Hyderabad, Andhra Pradesh, India

Research Site

Ahmedabad, Gujarat, India

Research Site

Bangalore, Karnataka, India

Research Site

Calicut, Kerala, India

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.

Time frame: 8 weeks

Change in the heart rate,Number of responders & control rates.

Time frame: 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

Time frame: 8 weeks

Data from ClinicalTrials.gov

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