Irbesartan Effects on Endothelial Dysfunction in Hypertensive Type II Diabetic Patients Comparing Atenolol (IREDIS)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Hypertension; Diabetes Mellitus Type 2

Treatments: Drug: Irbesartan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549133

L_9130

Details and patient eligibility

About

To show that Irbesartan improves endothelial dysfunction and the procoagulant state which are thought to be the possible mechanisms, inducing a generalized vasculopathy associated with microalbuminuria and vascular events in type II diabetic hypertensive patients

Enrollment: 44 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• non insulin dependent type II manifest diabetes with glycosilated HbA1c levels over %6.5-8
• mild to moderate hypertension stage I and stage II according to ESC-ESH 2003 (140-180 mmHg)

Exclusion criteria

• congestive heart failure
• azotemia
• insulin dependent diabetes
• liver insufficiency
• pregnancy
• cancer

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: Single Group Assignment

Masking: None (Open label)