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

ClinicalTrials.gov ID: NCT00098007

Public ClinicalTrials.gov record NCT00098007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 12, 2026, 5:18 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Six-month, Multicenter, Randomized, Open-label Study of the Safety, Tolerability and Efficacy of Two Neoral Doses in Addition to Certican and Steroids in de Novo Heart Transplant Recipients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00098007
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: 199 participants

Conditions and interventions

Conditions

Heart Transplantation

Interventions

Everolimus (Certican) Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 8, 2004
Primary completion: Jan 7, 2007
Completion: Jan 7, 2007
Last update posted: Feb 22, 2017

2004 – 2007

United States locations

U.S. sites: 12
U.S. states: 10
U.S. cities: 10

Facility	City	State	ZIP	Site status
The University of Alabama at Birmingham	Birmingham	Alabama	35294-0006	—
Cedar Sinai Medical Center	Los Angeles	California	900048	—
Tampa General Hospital	Tampa	Florida	33606	—
University of Minnesota	Minneapolis	Minnesota	55455	—
Newark Beth Israel Medical Center	Newark	New Jersey	07102	—
New York Presbyterian Medical Center	New York	New York	10032	—
Duke Clinical Research Institute	Durham	North Carolina	27710	—
University of Pennsylvania Medical Center	Philadelphia	Pennsylvania	19104	—
Temple University Hospital	Philadelphia	Pennsylvania	19140	—
Texas Heart Institute/St Lukes Hospital	Houston	Texas	77030	—
The Baylor College of Medicine/ The Methodist Hospital	Houston	Texas	77030	—
St Luke's Medical Center	Milwaukee	Wisconsin	53215	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00098007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 22, 2017 · Synced Sep 12, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00098007 live on ClinicalTrials.gov.

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