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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220261

Enrollment

350

Registered

2006-06-26

Start date

2006-06-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

investigational material(s) Generic name etc : VAH631 INN of investigational material : Therapeutic category code : 214 Antihypertensives Dosage and Administration for Investigational material : Oral

Eligibility

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Primary Outcomes: Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks. Secondary Outcomes: 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	—

Measure

Time frame

Primary Outcomes: Assessment of safety through reporting of adverse events, serious adverse events and deaths over 52 weeks. Secondary Outcomes: 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

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026