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Long-term VAH631 in Essential Hypertension
NCT00338936Phase 3
Key facts
- Status
- Completed
- Start
- May 2006
- Primary completion
- Sep 2007
- Sponsor
- Novartis
- Modality
- Small Molecules
- Conditions
- essential hypertension
01
Overview
Phase 3, open-label, single-arm trial of valsartan and hydrochlorothiazide in essential hypertension, sponsored by Novartis. Primary endpoint: Assessment of safety through reporting of adverse events, serious adverse events and deaths at 52 weeks. Started May 2006; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Valsartan + Hydrochlorothiazide
Combination therapy with Valsartan and Hydrochlorothiazide.
03
Who it enrols
Patients who successfully completed the core study (Protocol 1303) and are outpatients.
04
Endpoints
Primary
Assessment of safety through reporting of adverse events, serious adverse events and deaths
Secondary
Change from baseline in average sitting diastolic blood pressure
Change from baseline in average sitting systolic blood pressure
Change from baseline in average standing diastolic blood pressure
Change from baseline in average standing systolic blood pressure
Laboratory abnormalities
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