Hypertension and Cardiovascular Risk Factors

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

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

Secondary outcome:

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. 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.

Starting date: February 2004
Last updated: June 1, 2006