Valsartan/Hydrochlorothiazide Combination in Hypertensive Patients Not Controlled With Valsartan Alone

Condition(s) targeted: Hypertension

Intervention: valsartan plus hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis

This study will test the effectiveness and safety of a combination treatment in patients whose blood pressure is not controlled with a single medication.

Official title: Comparison of the Combination of Valsartan 320 mg Plus Hydrochlorothiazide 12.5 mg and Valsartan 320 mg Plus Hydrochlorothiazide 25 mg to Valsartan 320 mg in Mild to Moderate Hypertensive Patients Not Adequately Controlled With Valsartan 320 mg

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

Primary outcome: Change from baseline in diastolic blood pressure from baseline after 8 weeks

Secondary outcome:

Change from baseline in systolic blood pressure from baseline after 8 weeks

Change from baseline in standing systolic and diastolic blood pressure after 8 weeks

Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic pressure after 8 weeks

Diastolic blood pressure less than 90 mmHg after 8 weeks

Adverse events and serious adverse events at 8 weeks

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with mild to moderate hypertension

Exclusion Criteria:

- Severe hypertension

- History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart

rhythm

- Liver, kidney, or pancreas disease

- Insulin dependent diabetes

- Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Investigative Centers, Germany

Novartis Pharmaceuticals, Basel, Switzerland

Starting date: September 2004
Last updated: November 13, 2006