Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study)

A 52-week Extension to the Factorial Study to Evaluate the Efficacy and Safety of VAH631 (Valsartan and Hydrochlorothiazide Combined) and Alone in Essential Hypertensive Patients - Long Term Study of VAH631 in Patients With Essential Hypertension (Extension From B1303 Study) -

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00338936

Enrollment

362

Registered

2006-06-20

Start date

2006-05-31

Completion date

2007-09-30

Last updated

2011-11-08

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

Conditions

Hypertension

Keywords

Hypertension, Valsartan, Hydrochlorothiazide

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.

Interventions

DRUGValsartan + Hydrochlorothiazide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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: ClinicalTrials.gov · Data processed: Feb 4, 2026