Olmesartan Medoxomil and Diabetic Nephropathy

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sankyo Pharma Gmbh
• Treatments: Losartan; Olmesartan; Olmesartan Medoxomil

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)