Randomized, Parallel, Comparison, Double-Blind Efficacy & Safety Study of APROVEL Versus Placebo in Chinese Patients With Hypertensive Type II Diabetic Patients With Microalbuminuria (PRIME)

Sanofi

Status and phase

Completed

Phase 3

Conditions

Hypertension

Treatments

Drug: Irbesartan

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

L_9079

Details and patient eligibility

About

To evaluate the effects and safety of irbesartan on proteinuria in hypertensive patients with type Ⅱdiabetes mellitus.

Enrollment

241 patients

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Fasting plasma glucose of untreated type II diabetes mellitus patients greater than or equal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus and treatment > 3 months
The patients of normal BP, or hypertensive patients receiving antihypertensive medication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and the Seated diastolic blood pressure (SeDBP) is between 80-110mmHg;
Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timed overnight collection. Before randomization the patient must quality with two AERs of 3 days intervals in the absence of confounding factors such as urinary tract infection, acute febrile illness and cardiac failure. The two AERs measurement should be in the above defined range and the variability between the two AERs measurement must be <35%. Value of basal AER is calculated as the mean of the 2 measurements. The UAER measured using immunity nephelometer method (DCA2000);
Serum creatinine < 150umol/L(1.7mg/dl) and serum potassium in the normal lab range (3.5-5.5 mol/L);
18 Kg/m2less than or equal to BMI less than or equal to 35Kg/m2

Exclusion criteria