Hypertension and Cardiovascular Risk Factors
Information source: Novartis
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: VALSARTAN+HYDROCHLOROTHIAZIDE (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
Summary
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2
hypertension and cardiovascular risk factors.
Clinical Details
Official title: Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: Change from baseline systolic blood pressure at 8 weeks
Secondary outcome: Blood pressure less than 140/90 mmHg at 8 weeksReduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who give consent
Men and women 18 to 80 years of age
Patients with hypertension (systolic >159 mm, diastolic >100 mm)
Patients meeting laboratory criteria
Exclusion Criteria:
- Pregnant women
Women not using approved contraception methods
Secondary hypertension
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: February 2004
Last updated: June 1, 2006
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