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A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients

NCT00098007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2017-02-23

No results posted yet for this study

Summary

The study is designed to evaluate whether Neoral dose optimization together with a therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the pivotal cardiac trial while maintaining the efficacy.

This objective will be assessed by comparing renal function post-transplant between 2 groups of patients.

Conditions

  • Heart Transplantation

Interventions

DRUG

Everolimus (Certican)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-09
Primary Completion
2007-01-08
Completion
2007-01-08

Countries

  • United States
  • Australia
  • Austria
  • Brazil
  • Canada
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Companies

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 NCT00098007 on ClinicalTrials.gov