Long Term Study of VAH631 in Patients With Essential Hype... | NCT00338936

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

NCT00338936

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

362Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

Valsartan + Hydrochlorothiazide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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 Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Jun 16, 2006

First Submission Date that Met QC Criteria

Jun 16, 2006

First Posted Date

Jun 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

362Actual

Name	Type	Description	Arm Group Labels	Other Names
Valsartan + Hydrochlorothiazide	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharma Ag	Novartis Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068756	Valsartan
D006852	Hydrochlorothiazide

Ancestor Terms

ID	Term
D013777	Tetrazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided