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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: Completed Phase 2 study of Myocarditis and Giant Cell Myocarditis, sponsored by Mayo Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Interventions
- DRUG prednisone
- DRUG Cyclosporine
- DRUG methylprednisolone
- DRUG Muromonab-CD3
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 1999-12 |
| Est. Completion | 2006-07 |
| Phase | Phase 2 |
What the finished NCT00004482 record still lists
NCT00004482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 380-participant average among 5 other Myocarditis trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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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