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Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Information source: Sanofi
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Irbesartan (Drug); Irbesartan (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Bruno Jolain, Study Director, Affiliation: Sanofi

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The difference of urinary albumin excretion rate change

Secondary outcome:

Percentage of patients reaching target BP of 130/80mmHg

Adverse events

Eligibility

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Sanofi-Aventis Administrative Office, Shanghai, China
Additional Information

Starting date: May 2006
Last updated: September 14, 2009

Page last updated: August 20, 2015

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