Clinical Trial Details
| Trial ID: | L5886 |
| Source ID: | NCT00362960 |
| Associated Drug: | Olmesartan Medoxomil |
| Title: | Olmesartan Medoxomil and Diabetic Nephropathy |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Type 2 Diabetes Mellitus|Diabetic Nephropathy|Proteinuria|Renal Disease |
| Interventions: | DRUG: Olmesartan medoxomil|DRUG: Losartan |
| Outcome Measures: | Primary: 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: 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. |
| Sponsor/Collaborators: | Sponsor: Sankyo Pharma Gmbh |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 300 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT |
| Start Date: | 2003-05 |
| Completion Date: | 2004-09 |
| Results First Posted: | |
| Last Update Posted: | 2006-10-09 |
| Locations: | Frydlant v Cechach, Czech Republic|Liberec, Czech Republic|Prague, Czech Republic|Tartu, Estonia|Augsburg, Germany|Greifenstein-Beilstein, Germany|Hannover, Germany|Zwijndrecht, Netherlands|Grodzisk Mazowiecki, Poland|Krakow, Poland|Plock, Poland|Poznan, Poland|Pruszkow, Poland|Torun, Poland|Warsaw, Poland|Watlack, Poland|Wolomin, Poland|Wroclaw, Poland|Banska Bystrica, Slovakia|Kosice, Slovakia|Lucenec, Slovakia|Martin, Slovakia|Nitra, Slovakia|Nove Zamky, Slovakia|Sahy, Slovakia|Barcelona, Spain|Madrid, Spain |
| URL: | https://clinicaltrials.gov/show/NCT00362960 |
