Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

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

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12. 5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

Official title: A 6-Week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-Dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Change from baseline systolic blood pressure after 4 weeks

Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary outcome:

Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period

Blood pressure less than 140/90 mmHg after 6 weeks

Change from baseline diastolic blood pressure after 6 weeks

Change from baseline in blood and urine markers after 6 weeks

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female age 18 or older

- Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but

< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)

Exclusion Criteria:

- Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg

- History of secondary hypertension (including primary aldosteronism, renovascular

hypertension, pheochromocytoma etc.)

- History of myocardial infarction, stroke [e. g. cerebrovascular accident (CVA),

thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Starting date: December 2005
Last updated: March 20, 2008