Trials / Completed
CompletedNCT00828776
Pharmacodynamics and Non-Clinical Inferiority of Heparin Sodium (Cristália) Compared With the Product Liquemine (Roche) in Chronic Renal Failure
Clinical Trial of Pharmacodynamic Effects and Non-Clinical Inferiority of the Drug Heparin Sodium Produced by the Laboratory Cristália When Compared With the Product Liquemine of Roche Laboratory in Patients With Chronic Renal Failure
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Azidus Brasil · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study was to assess the safety in use of the drug Heparin Sodium, produced by Cristália Laboratory, compared drug Liquemine ®, manufactured by Roche Laboratory, and secondary purpose was to evaluate the non-inferiority clinical testing of the product on the product comparator and pharmacodynamic effect, as evidenced by analyzing the parameters and TTPA Anti-Xa in patients with chronic renal failure in treatment of hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Heparin sodic - Cristália | 5000UI/mL |
| BIOLOGICAL | heparin - Liquemine (Roche) | 5000UI/mL |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2008-02-01
- Completion
- 2008-03-01
- First posted
- 2009-01-26
- Last updated
- 2009-01-26
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT00828776. Inclusion in this directory is not an endorsement.