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NCT00048763 · ClinicalTrials.gov registry record · Phase 4
Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
A Phase 4 study, sponsored by Otsuka America Pharmaceutical.
- Completed
- Registry status
- Phase 4
- Development phase
- 75
- Enrollment target
NCT00048763 is a Phase 4 study that has completed, run by Otsuka America Pharmaceutical. The registered enrollment target is 75 participants.
The verdict
NCT00048763, a Phase 4 study, has completed, sponsored by Otsuka America Pharmaceutical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 75 participants
- Enrollment target
Study Summary
Juvenile primary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud's Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items from the refrigerator, their fingers may become cold, numb, hurt, and/or turn purple or white. Children with primary Raynaud's Phenomenon have no underlying systemic disease. The cause for their symptoms is unknown. The investigational drug, Pletal(cilostazol), which has been approved for other conditions, inhibits the ability of one type of blood cell, platelets, to form blood clots, and also widens narrowed blood vessels. It has been used in a variety of other conditions in which blood flow is decreased. This study will test the safety and effectiveness Pletal(cilostazol) to lessen the severity of the symptoms and decrease the number of primary Raynaud's episodes in juvenile patients.
Interventions
- DRUG Pletal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2001-10 |
| Est. Completion | 2003-06 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048763
The ClinicalTrials.gov registry entry for NCT00048763 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka America Pharmaceutical, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pletal is the first listed.
NCT00048763 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048763 about?
NCT00048763 is a clinical study titled "Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon". Juvenile primary Raynaud's (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. When children with primary Raynaud's Phenomenon are exposed to chilly or cold conditions from weather, cold temperatures, or even holding cold items f...
What is the current status of trial NCT00048763?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2001-10. Estimated completion is 2003-06.
What interventions are being tested in trial NCT00048763?
The interventions under investigation include: Pletal (DRUG).
Who is sponsoring clinical trial NCT00048763?
This trial is sponsored by Otsuka America Pharmaceutical, which has 10 total clinical trials registered on ClinicalTrials.gov.
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