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

Novartis

Status and phase: Completed; Phase 4

Conditions: Primary Hypertension

Treatments: Drug: valsartan/amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01241487

CVAA489AEG02

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

1

Experimental group

Description:

valsartan/amlodipine

Treatment:

Drug: valsartan/amlodipine