A Study to Describe Vascular and Renal Effects and Safety... | NCT00171353

Studies
A Study to Describe Vascular and Renal Effects and Safety of Valsartan in Patients With High Blood Pressure

NCT00171353

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

109Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

valsartan

Countries

Switzerland

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

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

Jul 2004

Primary Completion Date

Sep 2005Actual

Completion Date

Sep 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

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

One hundred twenty patients with arterial hypertension and albuminuria (some amount of albumin in urine) are given valsartan 80 mg and then160 mg to normalize blood pressure. Hydrochlorothiazide (diuretic) 12.5-25 mg added if necessary.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Name	Type	Description	Arm Group Labels	Other Names
valsartan	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in urine albumin excretion after 24 weeks
Change from baseline in an ultrasound measurement of blood flow after 24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Effect of blood pressure changes on urine albumin excretion rate and blood vessel function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Arterial hypertension without previous regular treatment
Urinary albumin excretion rate above 30 mg / 24h
30-65 years old

Exclusion Criteria:

Reno-vascular arterial hypertension
Therapy resistant edema
Chronic heart failure, angina pectoris
Diabetes mellitus

Other protocol-defined exclusion criteria may apply

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 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	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		Basel			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D000419	Albuminuria

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D011507	Proteinuria
D014555	Urination Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068756	Valsartan

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided