A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy

Novartis150 enrolled

Overview

This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Primary Hypertension

Interventions

valsartan/amlodipineDRUG

160/10 mg

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.\>/= 140/90 mmHg in non diabetics or \>/= 130/80 mmHg in diabetics Exclusion Criteria: * Patient having B.P.\>= 180/110 mmHg in non diabetics or \>= 160/100 mmHg in diabetics * Type 1 Diabetes or uncontrolled type 2 Diabetes. * PCI in last 12 months. * Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply

Locations (1)

Dr Ahmed Anwar Clinic,

Cairo, Egypt

Outcomes

Primary Outcomes

Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10)

Time frame: 4 weeks

Secondary Outcomes

Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration.

Time frame: 8 weeks

Safety and Tolerability of the Trial Medication

Time frame: 8 weeks

The incidence of Edema

Time frame: 8 weeks

Data from ClinicalTrials.gov

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