Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT00934167
Status:
UNKNOWN
Last Update Posted:
2010-10-27
First Post:
2009-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
Sponsor:
Azidus Brasil
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2010-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: