ong term study of VAH631 in patients with essential hypertension (Extension from B1303 study)

Phase 3

• Conditions: Hypertension

• Registration Number: JPRN-jRCT2080220261
• Lead Sponsor: ovartis Pharma K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 350

Inclusion Criteria

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.

Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcomes: <br>Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks. <br>Secondary Outcomes:<br> 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