Olmesartan Medoxomil and Diabetic Nephropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00362960
• Date of registration: 10/08/2006
• Prospective Registration: No
• Primary sponsor: Sankyo Pharma Gmbh
• Public title: Olmesartan Medoxomil and Diabetic Nephropathy
• Scientific title: Effect of Different Doses of Olmesartan Medoxomil Compared to Losartan on Proteinuria, Renal Function and Inflammatory Markers in Type 2 Diabetics With Nephropathy
• Date of first enrolment: May 2003
• Target sample size: 300
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00362960
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Czech Republic, Estonia, Germany, Netherlands, Poland, Slovakia, Spain

Contacts

• Name: H Haller, MD
• Affiliation: Hanover Medical School

Key inclusion & exclusion 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 ?-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)



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Disease

Type 2 Diabetes Mellitus

Proteinuria

Diabetic Nephropathy

Intervention(s)

Drug: Olmesartan medoxomil

Drug: Losartan

Primary Outcome(s)

proteinuria (total urinary protein excretion) from baseline.

Efficacy of olmesartan medoxomil doses compared to losartan in

patients with type 2 diabetes and nephropathy in terms of the change in

Secondary Outcome(s)

the protein pattern (nephelometry)

creatinine clearance (CLCR)

losartan in patients with type 2 diabetes and nephropathy in terms of

Efficacy of the treatment with olmesartan medoxomil dosages compared to

inflammatory markers (circulating serum markers).

change in:

Evaluate safety and tolerability of all treatments.

Secondary ID(s)

SE-866/29

Source(s) of Monetary Support

Please refer to primary and secondary sponsors