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NCT00004482 · ClinicalTrials.gov registry record · Phase 2

Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis

A Phase 2 study of Myocarditis and Giant Cell Myocarditis, sponsored by Mayo Clinic.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
1
Study location

NCT00004482 is a Phase 2 study of Myocarditis and Giant Cell Myocarditis that has completed, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 380-participant average among 5 other Myocarditis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00004482, a Phase 2 study of Myocarditis and Giant Cell Myocarditis, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target
1
Study location

Study Summary

OBJECTIVES: I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis. II. Compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms. III. Compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.

Conditions Studied

Myocarditis Giant Cell Myocarditis

Interventions

  • DRUG prednisone
  • DRUG Cyclosporine
  • DRUG methylprednisolone
  • DRUG Muromonab-CD3

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 1999-12
Est. Completion 2006-07
Phase Phase 2

Sponsor

Mayo Clinic

2,844 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00004482

The ClinicalTrials.gov registry entry for NCT00004482 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 380-participant average among 5 other Myocarditis trials with a reported enrollment target (89% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Myocarditis appearing as the primary indexed condition, and to 4 interventions - of which prednisone is the first listed.

NCT00004482 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT00004482 about?

NCT00004482 is a clinical study titled "Phase II Randomized Study of Muromonab-CD3, Cyclosporine, Methylprednisolone, and Prednisone in Patients With Giant Cell Myocarditis". OBJECTIVES: I. Assess the effect of immunosuppression with muromonab-CD3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis. II. Compare left ventric...

What is the current status of trial NCT00004482?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 1999-12. Estimated completion is 2006-07.

What conditions does trial NCT00004482 study?

This clinical trial studies the following conditions: Myocarditis, Giant Cell Myocarditis.

What interventions are being tested in trial NCT00004482?

The interventions under investigation include: prednisone (DRUG), Cyclosporine (DRUG), methylprednisolone (DRUG), Muromonab-CD3 (DRUG).

Who is sponsoring clinical trial NCT00004482?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00004482 being conducted?

This trial has 1 study location across Minnesota. 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.