| Trial ID: | L0294 |
| Source ID: | NCT00120328
|
| Associated Drug: |
Spp301
|
| Title: |
To Determine the Effects of Avosentan on Doubling of Serum Creatinine, End Stage Renal Disease and Death in Diabetic Nephropathy
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetic Nephropathy
|
| Interventions: |
DRUG: SPP301
|
| Outcome Measures: |
Primary: To determine the effect of each dose of avosentan on time to doubling of serum creatinine, end stage renal disease (ESRD) or death when administered on top of standard treatment in subjects with type 2 diabetes mellitus and diabetic nephropathy. | Secondary: To determine the effect of each dose of avosentan on: cardiovascular mortality|non-cardiovascular mortality|coronary or peripheral vascular revascularisations including amputations (except where due to trauma)|non-fatal acute myocardial infarction|stroke|congestive heart failure|unstable angina
|
| Sponsor/Collaborators: |
Sponsor: Speedel Pharma Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
2364
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: PREVENTION
|
| Start Date: |
2005-07
|
| Completion Date: |
2007-02
|
| Results First Posted: |
|
| Last Update Posted: |
2007-10-05
|
| Locations: |
Dr. Mark Warren, Greenville, North Carolina, 27834, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00120328
|
