Clinical Trial Details
| Trial ID: | L4959 |
| Source ID: | NCT00229684 |
| Associated Drug: | Tesaglitazar |
| Title: | ARMOR (Analyzing Renal Mechanisms of Creatinine Excretion in Patients On tesaglitazaR) |
| Acronym: | |
| Status: | TERMINATED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Tesaglitazar|DRUG: pioglitazone |
| Outcome Measures: | Primary: Effects of on tubular secretion of creatinine in type 2 diabetics after 12 weeks of treatment as assessed through determinations of:|Glomerular filtration rate (GFR) by iothalamate clearance|Endogenous creatinine clearance | Secondary: Effects of on tubular secretion of creatinine in type 2 diabetics after 24 weeks of treatment as assessed through determinations of:|GFR by iothalamate clearance|Endogenous creatinine clearance|The time course of change in serum creatinine concentration and GFR during a 24-week period of tesaglitazar treatment in type 2 diabetics|The effects of tesaglitazar on urinary protein excretion in type 2 diabetics by comparisons of urinary total protein and albumin excretion rates|The effects of tesaglitazar on urinary creatinine excretion in type 2 diabetics by comparisons of urinary total creatinine excretion rates|The pharmacokinetics of tesaglitazar during 24 weeks of therapy in type 2 diabetics.|The safety and tolerability of tesaglitazar in type 2 diabetics by assessments of adverse events, laboratory values, electrocardiogram, pulse, blood pressure, body weight, and physical examination. |
| Sponsor/Collaborators: | Sponsor: AstraZeneca |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 100 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: |
| Start Date: | 2004-09 |
| Completion Date: | 2006-06 |
| Results First Posted: | |
| Last Update Posted: | 2011-08-30 |
| Locations: | Research Site, Pasadena, California, United States|Research Site, Washington, District of Columbia, United States|Research Site, Gainesville, Florida, United States|Research Site, Miami, Florida, United States|Research Site, Orlando, Florida, United States|Research Site, Augusta, Georgia, United States|Research Site, Columbus, Georgia, United States|Research Site, New Orleans, Louisiana, United States|Research Site, Reno, Nevada, United States|Research Site, Flushing, New York, United States|Research Site, Durham, North Carolina, United States|Research Site, Cleveland, Ohio, United States|Research Site, Columbus, Ohio, United States|Research Site, Tulsa, Oklahoma, United States|Research Site, Cheswick, Pennsylvania, United States|Research Site, Philadelphia, Pennsylvania, United States|Research Site, Nashville, Tennessee, United States|Research Site, Midland, Texas, United States|Research Site, San Antonio, Texas, United States|Research Site, Gig Harbor, Washington, United States|Research Site, Seattle, Washington, United States |
| URL: | https://clinicaltrials.gov/show/NCT00229684 |
