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

A 52 Week, Open Label Extension to the Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00409851

Enrollment

1293

Registered

2006-12-11

Start date

2003-04-30

Completion date

2005-03-31

Last updated

2011-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

HYPERTENSION, VALSARTAN, AMLODIPINE,SAFETY

Brief summary

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

Interventions

DRUGvalsartan+amlodipine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

Germany, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026