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

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-16
• Study First Submitted QC: 2006-06-16
• Study First Posted: 2006-06-20
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-07
• Last Update Posted: 2011-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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.

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