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

Novartis2,714 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,714

Conditions

Hypertension

Interventions

valsartan plus hydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Investigative Centers, Germany

Novartis Pharmaceuticals

Basel, Switzerland

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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