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A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
NCT00098007 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00098007
The ClinicalTrials.gov registry entry for NCT00098007 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00098007 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Pennsylvania, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00098007?
The interventions under investigation include: Everolimus (Certican) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00098007?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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