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

Inclusion Criteria:

• Fasting plasma glucose of untreated type II diabetes mellitus patients greater than orequal to 7.0 mmol/L, or the time between diagnosis of type II diabetes mellitus andtreatment > 3 months

• The patients of normal BP, or hypertensive patients receiving antihypertensivemedication, Seated systolic blood pressure (SeSBP) is between 120-180mmHg and theSeated diastolic blood pressure (SeDBP) is between 80-110mmHg;

• Evidence of albuminuria defined as an AER of 20 and 500 ug/minute on a single timedovernight collection. Before randomization the patient must quality with two AERs of 3days 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 theabove 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 measuredusing 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:

• The above information is not intended to contain all considerations relevant to apatient's potential participation in a clinical trial.