Olmesartan Medoxomil and Diabetic Nephropathy

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

Official Title
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Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy

Conditions
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Type 2 Diabetes Mellitus, Diabetic Nephropathy, Proteinuria, Renal Disease

Intervention / Treatment
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* Drug: Olmesartan medoxomil
* Drug: Losartan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olmesartan medoxomil|nan|
|Drug: Losartan|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Diabetic Nephropathy, Inflammatory Markers, Proteinuria, Renal Disease