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) -
Sponsor study identifier
interventional
362
0 countries
N/A
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2007
Actual (reported)Study Completion
September 2007
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 16, 2006
Actual (reported)June 20, 2006
Actual (reported)September 2007
Actual (reported)September 2007
Actual (reported)Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Valsartan + Hydrochlorothiazide
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordNovartis Pharma Ag
Novartis Pharmaceuticals
362 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2006
First Posted
June 20, 2006
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
September 2007
Actual (reported)Study Completion
September 2007
Actual (reported)Last Updated
November 8, 2011
Record last verified: 2011-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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