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Canadian Cardiology de Novo Study: A Comparison Between Tacrolimus- and Cyclosporine- Based Immunoprophylactic Regimens

NCT00157014 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2017-06-05

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of tacrolimus in de novo heart transplantation.

Conditions

  • Heart Diseases
  • Heart Transplantation

Interventions

DRUG

Tacrolimus

Oral

DRUG

Cyclosporine

Oral

DRUG

Mycophenolate mofetil

Intravenous and Oral

DRUG

Methylprednisolone

Intravenous

DRUG

Prednisone

Oral

Sponsors & Collaborators

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Canada, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-10
Primary Completion
2008-07-18
Completion
2008-07-18

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT00157014 on ClinicalTrials.gov