Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud's Phenomenon
1 other identifier
interventional
75
1 country
18
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2001
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
November 7, 2002
CompletedFirst Posted
Study publicly available on registry
November 11, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2003
CompletedJuly 19, 2005
July 1, 2005
November 7, 2002
July 14, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (18)
Advanced Medical Clinical Therapeutics
Anchorage, Alaska, 99508, United States
Advanced Medical Research Institute
Fresno, California, 93710, United States
Madera Family Medical Group
Madera, California, 93637, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
LaRabida Children's Hospital
Chicago, Illinois, 60649, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
St. Louis University Health Sciences Center
St Louis, Missouri, 63104, United States
Children's Hospital
Omaha, Nebraska, 68114, United States
Asthma & Allergy Research Center
Newark, New Jersey, 07103, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Children's Hospital of Buffalo
Buffalo, New York, 14222, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
New York Medical College
Valhalla, New York, 10595, United States
Jobst Vascular Center
Toledo, Ohio, 43606, United States
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Monarch Research Associates
Norfolk, Virginia, 23510, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2002
First Posted
November 11, 2002
Study Start
October 1, 2001
Study Completion
June 1, 2003
Last Updated
July 19, 2005
Record last verified: 2005-07