Status:
COMPLETED
Olmesartan Medoxomil and Diabetic Nephropathy
Lead Sponsor:
Sankyo Pharma Gmbh
Conditions:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
Evaluation of several olmesartan dosages compared to losartan on proteinuria, renal function and inflammatory markers in patients with diabetic nephropathy
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00362960
Start Date
May 1 2003
End Date
September 1 2004
Last Update
October 9 2006
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Frýdlant, Czechia
2
Liberec, Czechia
3
Prague, Czechia
4
Tartu, Estonia