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

NCT01346215 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2011-05-02

No results posted yet for this study

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

BIOLOGICAL

heparin sodium

5000 UI/mL

BIOLOGICAL

heparin sodium

5000 UI/mL

Sponsors & Collaborators

  • Azidus Brasil

    collaborator INDUSTRY

  • Laboratório Químico Farmacêutico Bergamo Ltda.

    lead INDUSTRY

Principal Investigators

  • Marcelo A. C. Orlandi, Dr. · Instituto de Nefrologia de Campinas

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2012-02-29

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01346215 on ClinicalTrials.gov