| Trial ID: | L0207 |
| Source ID: | NCT01000545
|
| Associated Drug: |
Sulodexide
|
| Title: |
The Efficacy and Safety Study of Sulodexide in Filipino Diabetic Patients With Chronic Kidney Disease
|
| Acronym: |
DEFINE
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease
|
| Interventions: |
DRUG: Sulodexide|DRUG: placebo capsules
|
| Outcome Measures: |
Primary: macroalbuminuria and serum creatinine, 52 weeks | Secondary: adverse events, 52 weeks
|
| Sponsor/Collaborators: |
Sponsor: Corbridge Group Philippines, Inc. | Collaborators: Alfasigma S.p.A.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
1508
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2009-11
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2009-10-30
|
| Locations: |
Mary Mediatrix Medical Center, Lipa City, Batangas, Philippines|Rizal Private Clinics, Metro Manila, Rizal, Philippines|Holy Child Hospital, Dumaguete City, Philippines|Victoriano R. Potenciano Medical Center, Mandaluyong City, Philippines|Metropolitan Medical Center, Manila, Philippines|Manila Adventist Medical Center, Pasay City, Philippines|The Medical City, Pasig City, Philippines
|
| URL: |
https://clinicaltrials.gov/show/NCT01000545
|
