Olmesartan Medoxomil and Diabetic Nephropathy

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetic Nephropathy; Proteinuria; Renal Disease

• Registration Number: NCT00362960
• Lead Sponsor: Sankyo Pharma Gmbh

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-05
• Study Completion: 2004-09
• Status Verified: 2006-08
• Study First Submitted: 2006-08-10
• Study First Submitted QC: 2006-08-11
• Study First Posted: 2006-08-15
• Last Update Submitted: 2006-10-06
• Last Update Posted: 2006-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of olmesartan medoxomil doses compared to losartan in
patients with type 2 diabetes and nephropathy in terms of the change in
proteinuria (total urinary protein excretion) from baseline.

Secondary Outcome Measures

Name	Time	Method
Efficacy of the treatment with olmesartan medoxomil dosages compared to
losartan in patients with type 2 diabetes and nephropathy in terms of
change in:
creatinine clearance (CLCR)
the protein pattern (nephelometry)
inflammatory markers (circulating serum markers).
Evaluate safety and tolerability of all treatments.