Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)

Condition(s) targeted: Hypertension

Intervention: Valsartan + Amlodipine besilate (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis, Study Chair, Affiliation: Novartis

The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

Official title: A 54-Week Extension to the Multi-Center, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Factorial Study to Evaluate the Efficacy and Safety of VAA489 (Valsartan and Amlodipine Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAA489 in Patients With Essential Hypertension (Extension From A1301 Study)

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Safety assessed by serious and non-serious adverse events

Secondary outcome:

Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure

Laboratory tests

Vital signs

Electrocardiogram (ECG)

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participation in study CVAA489A1301

- Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 trial was well

controlled

- Outpatients

Exclusion Criteria:

- Presence of major protocol violation in Study CVAA489A1301

- Patients who experienced any adverse events considered serious and drug related in

Study CVAA489A1301

Other protocol-defined inclusion/exclusion criteria may apply

Novartis Investigative Site, Fukuoka, Japan

Starting date: February 2007
Last updated: October 16, 2007