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...
Date First Received: June 16, 2006
Last Updated: October 16, 2007
Verified by: Novartis, October 2007
Clinical Trial Phase: Phase 3 | Start Date: May 2006
Overall Status: Completed
Estimated Enrollment: 350
Brief Summary
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) -”
Condition Keyword(s):
Intervention(s):
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
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Intervention(s) in this Clinical Trial
- Drug: Valsartan + Hydrochlorothiazide
Outcome Measures for this Clinical Trial
Primary Measures
- Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.
Secondary Measures
- 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: 80 Years
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharma Ag Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00338936
Study ID Number: CVAH631B1303E1
ClinicalTrials.gov Identifier: NCT00338936
Health Authority: Japan: Ministry of Health, Labor and Welfare
Clinical Trials Authorship and Review
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