Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00338936
- Lead Sponsor
- Novartis
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 362
Inclusion Criteria
- Patients who successfully complete the core study (Protocol 1303)
- Outpatients
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Exclusion Criteria
- Presence of crucial protocol violation in Protocol 1303
- Patients who experienced any adverse events considered serious and drug related in Protocol 1303.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks.
- Secondary Outcome Measures
Name Time Method 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