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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 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.

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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

Heart Transplantation

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

FieldValue
Enrollment Target 199 participants
Start Date 2004-08-09
Est. Completion 2007-01-08
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT00098007

The ClinicalTrials.gov registry entry for NCT00098007 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 542-participant average among 4 other Heart Transplantation trials with a reported enrollment target (63% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.