One Year Study to Evaluate the Safety of the Combination of Valsartan and Amlodipine in Patients With Hypertension
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan+amlodipine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis pharmaceuticals, Study Chair, Affiliation: Sponsor
Summary
A ONE YEAR SAFETY STUDY FOR PATIENTS WHO COMPLETE STUDY VAA489A2201.
Clinical Details
Official title:
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.
Study design: Interventional, Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough.
Secondary outcome: Change from baseline (Visit 2) in mean sitting systolic blood pressure at troughChange from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough Sitting and standing pulse
Eligibility
Minimum age: 18 Years.
Gender(s): Both.
Criteria:
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 and Contacts
Sites in Germany, Germany
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
NOVARTIS PATIENT RECRUITMENT WEBSITE
Starting date:
April 2003
Last updated: July 6, 2007
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