Valsartan Intensified Primary Care Reduction of Blood Pressure Study
Information source: Novartis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Valsartan, hydrochlorothiazide (Drug); Valsartan, amlodipine, hydrochlorothiazide (Drug); usual care (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Study Director, Study Director, Affiliation: Novartis Pharmaceuticals
Overall contact:
Novartis Pharmaceuticals, Phone: 862-778-8300
Summary
This study will assess the efficacy of an intensive blood pressure management strategy
compared to usual care in a primary care (general practice) setting.
Clinical Details
Official title: A Phase IV Clinical Trial of Intensified Blood Pressure Management in Primary Care Using Valsartan Alone and as Combination Anti-Hypertensive Therapy
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of patients who achieve pre-specified BP target
Secondary outcome: Change in mean sitting systolic and diastolic BPrate of adverse events proportion of patients who achieve prespecified BP target changes in absolute cardiovascular risk all-cause mortality; fatal and non-fatal cardiovascular events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- hypertension requiring drug treatment
Exclusion Criteria:
- significantly elevated blood pressure (severe hypertension)
- requiring 3 or more antihypertensive drugs
- severe kidney disease
Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Novartis Pharmaceuticals, Phone: 862-778-8300
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Additional Information
Starting date: May 2009
Last updated: May 14, 2009
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