Irbesartan in Chinese Hypertensive Diabetics With Microalbuminuria

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Irbesartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00334581

IRBES_L_00907

Details and patient eligibility

About

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

Enrollment: 192 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 2 patient groups

1

Experimental group

Description:

Irbesartan 150mg

Treatment:

Drug: Irbesartan

Drug: Irbesartan

2

Experimental group

Description:

Irbesartan 300mg

Treatment:

Drug: Irbesartan

Drug: Irbesartan