Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon

This study has been completed.
Sponsor:
Information provided by:
Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00048763
First received: November 7, 2002
Last updated: July 14, 2005
Last verified: July 2005

November 7, 2002
July 14, 2005
October 2001
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Complete list of historical versions of study NCT00048763 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
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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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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Raynaud's Disease
Drug: Pletal
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2003
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Inclusion critera:

  • 5 to 6 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's
Both
5 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00048763
21-01-335
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Otsuka America Pharmaceutical
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Otsuka America Pharmaceutical
July 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP