Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
Completed · Phase 4
Conditions studied: Raynaud's Disease
In brief
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.
Key facts
- Study ID
- NCT00048763
- Run by
- Otsuka America Pharmaceutical
- People needed
- 75
- Starts
- 2001-10-01
- Expected to finish
- 2003-06-01
- Last updated by the study team
- 2005-07-19
Who can join
Age: 5 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Advanced Medical Clinical Therapeutics — Anchorage, Alaska, United States
- Advanced Medical Research Institute — Fresno, California, United States
- Madera Family Medical Group — Madera, California, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- LaRabida Children's Hospital — Chicago, Illinois, United States
- Children's Hospital Boston — Boston, Massachusetts, United States
- St. Louis University Health Sciences Center — St Louis, Missouri, United States
- Children's Hospital — Omaha, Nebraska, United States
- Asthma & Allergy Research Center — Newark, New Jersey, United States
- SUNY Downstate Medical Center — Brooklyn, New York, United States
- Children's Hospital of Buffalo — Buffalo, New York, United States
- Schneider Children's Hospital — New Hyde Park, New York, United States
- New York Medical College — Valhalla, New York, United States
- Jobst Vascular Center — Toledo, Ohio, United States
- The Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
- Medical University of South Carolina — Charleston, South Carolina, United States
- Monarch Research Associates — Norfolk, Virginia, United States
- Children's Hospital and Regional Medical Center — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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