Irbesartan in Chinese Hypertensive Diabetics With Microal... | NCT00334581

Studies
Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

NCT00334581

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 15, 2009Estimated

Enrollment

192Actual

Phase

Phase 4

Conditions

Hypertension

Interventions

Irbesartan
Irbesartan

Countries

China

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

Sep 2009

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

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Jun 7, 2006

First Submission Date that Met QC Criteria

Jun 7, 2006

First Posted Date

Jun 8, 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

Sep 14, 2009

Last Update Posted Date

Sep 15, 2009Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Description Module

Brief Summary

Primary objective:

To determine if irbesartan 300mg is better than 150mg in protecting the kidneys in hypertensive patients with diabetes and microalbuminuria.

Secondary objectives:

To determine how well irbesartan 300mg is tolerated versus 150mg
To determine the percentage of patients reaching the blood pressure target of 130/80 mmHg

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

192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Irbesartan 150mg	Drug: Irbesartan
2	Experimental	Irbesartan 300mg	Drug: Irbesartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irbesartan	Drug	Administration throughout the study period	1
Irbesartan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference of urinary albumin excretion rate change		at week 24

Secondary Outcomes

Measure	Description	Time Frame
Percentage of patients reaching target BP of 130/80mmHg		At week 24
Adverse events		From the beginning to the end of the study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hypertensive patients, treated or untreated, with type 2 diabetes and urinary albumin excretion rate 20-200ug/min.
Blood pressure of < 180/110mmHg at baseline
Normal serum creatinine

Exclusion Criteria:

Type 1 diabetes
Use of angiotensin converting enzyme inhibitors or angiotensin receptor blockers in the 5 weeks before recruitment
Pregnant or lactating women
Severe hypertension
Overt nephropathy
Allergy to study drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

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
Bruno Jolain	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Shanghai			China

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
D000077405	Irbesartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided