NCT Number: NCT00048763
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 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.
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Notify MeKey information
Conditions
Age range
5 year–16 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Advanced Medical Clinical Therapeutics, Anchorage, Alaska, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion critera:
- 5 to 6 years old
- fulfill diagnostic criteria for primary or secondary Raynaud's
Treatment and study plan
Sponsors and collaborators
Lead sponsor
Otsuka America Pharmaceutical
Industry
Registry information
Important dates
- Study start
- 2001
- Study completion
- 2003
- First posted
- Nov 11, 2002
- Registry last updated
- Jul 19, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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