Trials / Unknown
UnknownNCT00934167
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLISM.
- Status
- Unknown
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Azidus Brasil · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | heparin sodium - Hipolabor | 5.000 UI/0,25mL |
| BIOLOGICAL | Heparin sodium - APP | 5.000 USP/mL |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2010-11-01
- Completion
- 2011-09-01
- First posted
- 2009-07-08
- Last updated
- 2010-10-27
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00934167. Inclusion in this directory is not an endorsement.