Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria - Full Text View

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Irbesartan	Phase IV

MedlinePlus related topics:

Diabetes High Blood Pressure

ChemIDplus related topics:

Irbesartan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Study of Irbesartan 150mg Verses 300mg in Chinese Hypertensive Patients With Diabetes and Microalbuminuria

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

The difference of urinary albumin excretion rate change [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients reaching target BP of 130/80mmHg [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: From the beginning to the end of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	May 2006
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Irbesartan 150mg	Drug: Irbesartan Administration throughout the study period
2: Experimental Irbesartan 300mg	Drug: Irbesartan Administration throughout the study period

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334581

Locations


China
	Sanofi-Aventis
	Shanghai, China

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators


Study Director:	Bruno Jolain	Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	IRBES_L_00907
First Received:	June 7, 2006
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00334581
Health Authority:	China: State Food and Drug Administration

Study placed in the following topic categories:

Irbesartan

Vascular Diseases

Diabetes Mellitus

Angiotensin II

Hypertension

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Cardiovascular Diseases

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008

Sponsors and Collaborators:	Sanofi-Aventis Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00334581