Trials / Unknown
UnknownNCT00914472
Comparison of Two Heparin Formulations in Patients With Chronic Renal Failure.
A Randomized Non-inferiority Clinical Trial of Heparin Produced by Hipolabor Laboratory(PARINEX®) in Comparation With Heparin Produced by APP PHARMACEUTICALS in Patients With Chronic Renal Failure.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Azidus Brasil · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Investigate, through a randomized, open, parallel and comparative, non-inferiority of heparin sodium produced by laboratory Hipolabor compared to heparin manufactured by APP in patients on hemodialysis due to renal failure, through the control of hemostasis, verified by formation of clot (fibrin) in the hemodialysis system and pharmacodynamic parameters (TTPA and Anti-Xa) during the use of heparin
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | heparin sodium - APP | Heparin 5000 IU / mL |
| BIOLOGICAL | Heparin sodium - Hipolabor | Heparin 5000 IU / mL |
Timeline
- Start date
- 2010-04-01
- Primary completion
- 2011-03-01
- First posted
- 2009-06-05
- Last updated
- 2010-10-27
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00914472. Inclusion in this directory is not an endorsement.