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

Condition(s) targeted: Hypertension

Intervention: Valsartan + Hydrochlorothiazide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

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.

Official title: A 52-Week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Secondary outcome:

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

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Starting date: May 2006
Last updated: October 16, 2007