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Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
This study has been completed.
Study NCT00048763   Information provided by Otsuka America Pharmaceutical
First Received: November 7, 2002   Last Updated: July 14, 2005   History of Changes

November 7, 2002
July 14, 2005
October 2001
 
 
 
Complete list of historical versions of study NCT00048763 on ClinicalTrials.gov Archive Site
 
 
 
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.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Raynaud's Disease
Drug: Pletal
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
75
June 2003
 

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
Otsuka America Pharmaceutical
 
 
Otsuka America Pharmaceutical
July 2005

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