CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Mycophenolate Sodiumdrug
Likely dose
Mycophenolate Sodium 1440mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00574197
NCT00574197Phase 4Completed
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Assessment of Gastrointestinal Tolerability and Efficacy of Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

Cedars-Sinai Medical Center·interventional·Posted Dec 17, 2007·Updated Jul 30, 2020

In Brief

A Phase 4 clinical trial evaluating Mycophenolate Sodium for Gastrointestinal Symptoms and Heart Transplantation. Completed, enrolled 11 participants across 1 site.

Detailed Summary

Mycophenolate sodium (Myfortic®) is a newly developed enteric-coated tablet version of mycophenolate mofetil (Cellcept®) which is currently used as therapy for the prevention of transplant rejection. Myfortic® was developed to improve the gastrointestinal tolerability of Cellcept®. The new enteric-coated, Myfortic® is presently FDA approved for the prevention of acute kidney rejection only. There is no clinical data of its use in heart transplant patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastrointestinal Symptoms, Heart Transplantation
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2007
Enrollment StartJun 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 18.5 years ago

Interventions

Mycophenolate Sodiumdrug

1440mg/day (720mg by mouth, twice a day)