Clinical Trial Details
| Trial ID: | L6482 |
| Source ID: | NCT00287183 |
| Associated Drug: | Pf-04494700 (Ttp488) |
| Title: | 6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetic Nephropathy |
| Interventions: | DRUG: PF-04494700 (TTP488)|OTHER: Placebo |
| Outcome Measures: | Primary: Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR), from baseline to end of treatment (Month 6). | Secondary: To evaluate treatment on estimated GFR and serum creatinine, evaluated for change from baseline to months 3 & 6|To evaluate the effects of TTP488 on other relevant biomarkers, evaluated at months 1, 3 & 6|To evaluate the safety of TTP488, Ongoing|To evaluate the PK profile of oral TTP488., Ongoing|To evaluate the effect of treatment with TTP488 on UACR, evaluated from baseline to month 3 visit |
| Sponsor/Collaborators: | Sponsor: Pfizer |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE2 |
| Enrollment: | 110 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2006-02 |
| Completion Date: | 2009-08 |
| Results First Posted: | |
| Last Update Posted: | 2009-10-01 |
| Locations: | Pfizer Investigational Site, Red Deer, Alberta, T4N 6V7, Canada|Pfizer Investigational Site, Penticton, British Columbia, V2A 5C8, Canada|Pfizer Investigational Site, Vancouver, British Columbia, V6E 1M7, Canada|Pfizer Investigational Site, Burlington, Ontario, L7M 4Y1, Canada|Pfizer Investigational Site, Courtice, Ontario, L1E 3C3, Canada|Pfizer Investigational Site, Fort Erie, Ontario, L2A 1Z3, Canada|Pfizer Investigational Site, Hamilton, Ontario, L8M 1K7, Canada|Pfizer Investigational Site, Kitchener, Ontario, N2G 1N9, Canada|Pfizer Investigational Site, Kitchener, Ontario, N2H 5Z8, Canada|Pfizer Investigational Site, Millon, Ontario, L9T 0H7, Canada|Pfizer Investigational Site, North Bay, Ontario, P1B 2H3, Canada|Pfizer Investigational Site, Oakville, Ontario, L6H 3P1, Canada|Pfizer Investigational Site, Saint Catherines, Ontario, L2N 7H8, Canada|Pfizer Investigational Site, Scarborough, Ontario, M1H 3G4, Canada|Pfizer Investigational Site, Smith Falls, Ontario, K7A 4W8, Canada|Pfizer Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Pfizer Investigational Site, Toronto, Ontario, M4N-3M5, Canada|Pfizer Investigational Site, Toronto, Ontario, M4R 2G4, Canada|Pfizer Investigational Site, Saskatoon, Saskatchewan, S7K 0H6, Canada |
| URL: | https://clinicaltrials.gov/show/NCT00287183 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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