Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

Novartis362 enrolled

Overview

This study is designed to provide long-term safety and efficacy data for the combination doses of VAH (VAL/ HCTZ) 40/6.25mg and 80/12.5mg in essential hypertensive patients. The 350 patients (approximately) who have successfully finished the core trial CVAH631B1303 and signed consent for the extension will be enrolled into this study.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

362

Conditions

Hypertension

Interventions

Valsartan + HydrochlorothiazideDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients who successfully complete the core study (Protocol 1303) * Outpatients Exclusion Criteria: * Presence of crucial protocol violation in Protocol 1303 * Patients who experienced any adverse events considered serious and drug related in Protocol 1303.

Outcomes

Primary Outcomes

Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.

Secondary Outcomes

Change from baseline in average sitting diastolic blood pressure after 52 weeks

Change from baseline in average sitting systolic blood pressure after 52 weeks

Change from baseline in average standing diastolic blood pressure after 52 weeks

Change from baseline in average standing systolic blood pressure after 52 weeks

Laboratory abnormalities after 52 weeks

Data from ClinicalTrials.gov

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