A Study of VAH631 in Patients With Essential Hypertension... | NCT00311740

Studies
A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

NCT00311740

Sponsor

Novartis

Status

Completed

Last Update Posted

Feb 23, 2017Actual

Enrollment

582Actual

Phase

Phase 3

Conditions

Hypertension

Interventions

Valsartan
Hydrochlorothiazide

Countries

Japan

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 Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

Status Module

Record Verification Date

Feb 2017

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

Mar 2006

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Apr 4, 2006

First Submission Date that Met QC Criteria

Apr 4, 2006

First Posted Date

Apr 6, 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

Feb 21, 2017

Last Update Posted Date

Feb 23, 2017Actual

Description Module

Brief Summary

The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.

This study is being conducted in Japan.

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

582Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in systolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Essential hypertension measured by mercury sphygmomanometer
Outpatients

Exclusion Criteria:

Secondary hypertension or suspected of having secondary hypertension.
A history of malignant hypertension
Severe hypertension
Significant heart, renal, hepatic diseases or significant cerebrovascular disorder
Gout Other protocol-defined inclusion/exclusion criteria may apply

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novatis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		Tokyo			Japan

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

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