Olmesartan Medoxomil and Diabetic Nephropathy
Type 2 Diabetes Mellitus, Diabetic Nephropathy, Proteinuria
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Diabetic Nephropathy, Inflammatory Markers, Proteinuria, Renal Disease
Eligibility Criteria
Inclusion Criteria: Male or female European out-patients Greater than or equal to 30 years of age Type 2 diabetes first diagnosed at greater than or equal to 30 years of age Urinary protein excretion between 200-4000 mg/day exclusive Mean sitting dBP less than or equal to 110 mgHg Medically justifiable to withdraw antihypertensive treatment due to poor tolerability or inefficacy of previous treatment, or verification that treatment is still necessary Exclusion Criteria: Females pregnant, nursing or planning to become pregnant or were of childbearing potential and not using acceptable methods of contraception Secondary forms of hypertension other than diabetic nephropathy, malignant hypertension or patients with sitting dBP exceeding 110 mmHg or sitting sBP exceeding 200 mmHg ECG evidence of 2nd or 3rd degree AV-block, atrial fibrillation, cardiac arrhythmia (requiring therapy) or bradycardia Presence of significant cardiovascular disease Significant cerebrovascular disease, gastrointestinal, haematological or hepatic disease or myocardial infarction in last 12 months or a previous history of any serious underlying disease Concurrent renal disease, nephrectomy and/or renal transplant, serum creatinine level greater than or equal to 2.0 mg/dL or creatinine clearance CLCR less than or equal to 50 mL/min Clinically significant lab abnormalities (ASAT/SGOT, ALAT/SGPT and γ-GT ) Serum potassium level < 2.5 mmol/L or > 5.5 mmol/L Treatment of concurrent indications with drugs or medication which could have influenced BP History of hypersensitivity, lack of response or contraindication to Ang II-antagonists, HCTZ or atenolol, or hypersensitivity to related drugs (cross-allergy)