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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: valsartan+amlodipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00409851

CVAA489A2201E1

Details and patient eligibility

About

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

Enrollment: 1,293 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)