One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension

Phase 3CompletedNCT00409851

Novartis1,293 enrolled

Overview

A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,293

Conditions

Hypertension

Interventions

valsartan+amlodipineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * SUCCESSFUL COMPLETION OF VAA489A2201 CORE TRIAL * VISIT 7 BLOOD PRESSURE MUST BE MSDBP ≤ 95 mmHg AND MSSBP ≤ 150 mmHg Exclusion Criteria: * PATIENTS WHO EXPERIENCED ANY ADVERSE EVENTS CONSIDERED SERIOUS AND DRUG RELATED IN VAA489A2201 CORE * Other protocol-defined exclusion criteria may apply

Locations (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Unnamed facility

Sites in Germany, Germany

Outcomes

Primary Outcomes

Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.

Secondary Outcomes

Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough

Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough

Sitting and standing pulse

Data from ClinicalTrials.gov

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