Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension

Novartis607 enrolled

Overview

The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

607

Conditions

Hypertension

Interventions

valsartan plus hydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed severe hypertension Exclusion Criteria: * Inability to discontinue all prior antihypertensive medications * Heart failure of any kind * History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease * Diabetes with poor glucose control * Allergy to certain medications used to treat high blood pressure Other protocol-defined exclusion criteria may apply.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Blood pressure less than 140/90 mmHg after 4 weeks

Secondary Outcomes

Blood pressure less than 140/90 mmHg after 6 weeks

Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks

Systolic blood pressure less than 140 mmHg after 4 and 6 weeks

Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks

Adverse events and serious adverse events at each study visit for 6 weeks

Data from ClinicalTrials.gov

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