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
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2
hypertension and cardiovascular risk factors.
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
Blood pressure less than 140/90 mmHg at 8 weeks
Reduction 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
Minimum age: 18 Years.
Maximum age: 80 Years.
- 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
- Pregnant women
Women not using approved contraception methods
Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Starting date: February 2004
Last updated: June 1, 2006