Long Term Study of Valsartan and Amlodipine in Patients With Essential Hypertension (Extension to Study CVAA489A1301)
Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
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
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
Minimum age: 20 Years.
Maximum age: N/A.
- Participation in study CVAA489A1301
- Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 trial was well
- Presence of major protocol violation in Study CVAA489A1301
- Patients who experienced any adverse events considered serious and drug related in
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Investigative Site, Fukuoka, Japan
Starting date: February 2007
Last updated: October 16, 2007