Olmesartan Medoxomil and Diabetic Nephropathy

Condition(s) targeted: Type 2 Diabetes Mellitus; Diabetic Nephropathy; Proteinuria; Renal Disease

Intervention: Olmesartan medoxomil (Drug); Losartan (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sankyo Pharma Gmbh

Official(s) and/or principal investigator(s):
H Haller, MD, Principal Investigator, Affiliation: Hanover Medical School

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

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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

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:

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.

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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)

Frydlant v Cechach, Czech Republic

Prague, Czech Republic

Liberec, Czech Republic

Tartu, Estonia

Greifenstein-Beilstein, Germany

Hannover, Germany

Augsburg, Germany

Zwijndrecht, Netherlands

Warsaw, Poland

Wroclaw, Poland

Wolomin, Poland

Watlack, Poland

Grodzisk Mazowiecki, Poland

Krakow, Poland

Pruszkow, Poland

Torun, Poland

Poznan, Poland

Plock, Poland

Kosice, Slovakia

Sahy, Slovakia

Martin, Slovakia

Lucenec, Slovakia

Nove Zamky, Slovakia

Banska Bystrica, Slovakia

Nitra, Slovakia

Madrid, Spain

Barcelona, Spain

Starting date: May 2003
Ending date: September 2004
Last updated: October 6, 2006