Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00098007 · ClinicalTrials.gov registry record · Phase 3
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
A Phase 3 study of Heart Transplantation, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT00098007: Completed Phase 3 study of Heart Transplantation, sponsored by Novartis Pharmaceuticals.
NCT00098007 is a Phase 3 study of Heart Transplantation that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 199 participants, below the 542-participant average among 4 other Heart Transplantation trials with a reported enrollment target (63% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00098007, a Phase 3 study of Heart Transplantation, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
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 Studied
Interventions
- DRUG Everolimus (Certican)
Study Locations (20)
Other
- - Darlinghurst
- - Innsbruck
- - Vienna
- - São Paulo
Pennsylvania
- University of Pennsylvania Medical Center - Philadelphia
- Temple University Hospital - Philadelphia
Texas
- Texas Heart Institute/St Lukes Hospital - Houston
- The Baylor College of Medicine/ The Methodist Hospital - Houston
Alabama
- The University of Alabama at Birmingham - Birmingham
California
- Cedar Sinai Medical Center - Los Angeles
Florida
- Tampa General Hospital - Tampa
Minnesota
- University of Minnesota - Minneapolis
New Jersey
- Newark Beth Israel Medical Center - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2004-08-09 |
| Est. Completion | 2007-01-08 |
| Phase | Phase 3 |
What the finished NCT00098007 record still lists
NCT00098007 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, below the 542-participant average among 4 other Heart Transplantation trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Heart Transplantation appearing as the primary indexed condition, and to 1 intervention - of which Everolimus (Certican) is the first listed.
NCT00098007 names 20 study sites across 15 states, led by Other, Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT00098007 about?
NCT00098007 is a clinical study titled "A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients". 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-transpl...
What is the current status of trial NCT00098007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2004-08-09. Estimated completion is 2007-01-08.
What conditions does trial NCT00098007 study?
This clinical trial studies the following conditions: Heart Transplantation.
What interventions are being tested in trial NCT00098007?
The interventions under investigation include: Everolimus (Certican) (DRUG).
Who is sponsoring clinical trial NCT00098007?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00098007 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Transplantation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients
COMPLETED · Phase 3
-
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
COMPLETED · Phase 3
-
Belatacept in De Novo Heart Transplantation
RECRUITING · Phase 2
-
Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation
COMPLETED
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04312126 · 199 participants
The Beneficial Effects of Naps on Motor Learning
- NCT04951622 · 199 participants · Phase 3
A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
- NCT06474533 · 199 participants
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI