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A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery

NCT01352039 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 544

Last updated 2012-10-16

No results posted yet for this study

Summary

The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

Conditions

  • Hip Fracture Surgery

Interventions

BIOLOGICAL

Heparin Sodium - Eurofarma

Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

BIOLOGICAL

Heparin Sodium - APP Pharmaceuticals

Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Sponsors & Collaborators

  • Eurofarma Laboratorios S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-10-31
Completion
2012-10-31

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 NCT01352039 on ClinicalTrials.gov