NCT01346215

Study of Clinical Non-inferiority of Actparin® (Laboratorio Bergamo) Compared to Heparin Sodium (APP Pharmaceuticals), in Patients With Chronic Renal Failure

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Laboratório Químico Farmacêutico Bergamo Ltda. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate clinical non-inferiority, pharmacodynamic effect and safety of Actparin® (heparin sodium - Laboratório Químico Farmacêutico Bergamo Ltd.) compared to Heparin Sodium (APP Pharmaceuticals) in patients with renal failure under hemodialysis treatment.

Conditions

• Chronic Renal Failure

Interventions

Type	Name	Description
BIOLOGICAL	heparin sodium	5000 UI/mL
BIOLOGICAL	heparin sodium	5000 UI/mL

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2011-05-02
• Last updated: 2011-05-02

Locations

1 site across 1 country: Brazil