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

This study has been completed.
Information provided by:
Otsuka America Pharmaceutical Identifier:
First received: November 7, 2002
Last updated: July 14, 2005
Last verified: July 2005
Juvenile secondary Raynaud’s (ray-knows) Phenomenon is a disorder of the blood vessels in the fingers and sometimes can affect the toes, nose, or ears. Children with secondary Raynaud’s Phenomenon have an underlying condition such as systemic lupus, scleroderma, or mixed connective tissue disease. When children with secondary Raynaud’s 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. 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 secondary Raynaud’s episodes in juvenile patients.

Condition Intervention Phase
Raynaud's Disease
Drug: Pletal
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Otsuka America Pharmaceutical:

Estimated Enrollment: 75
Study Start Date: October 2001
Estimated Study Completion Date: June 2003

Ages Eligible for Study:   5 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • 5 to 16 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00048776

United States, Alaska
Advanced Medical Clinical Therapeutics
Anchorage, Alaska, United States, 99508
United States, California
Advanced Medical Research Institute
Fresno, California, United States, 93710
Madera Family Medical Group
Madera, California, United States, 93637
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
United States, Illinois
LaRabida Children's Hospital
Chicago, Illinois, United States, 60649
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis University Health Sciences Center
St. Louis, Missouri, United States, 63104
United States, Nebraska
Children's Hospital
Omaha, Nebraska, United States, 68114
United States, New Jersey
Asthma & Allergy Research Center
Newark, New Jersey, United States, 07103
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Children's Hospital of Buffalo
Buffalo, New York, United States, 14222
Schneider Children's Hospital
New Hyde Park, New York, United States, 11040
New York Medical College
Valhalla, New York, United States, 10595
United States, Ohio
Jobst Vascular Center
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
The Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Virginia
Monarch Research Associates
Norfolk, Virginia, United States, 23510
United States, Washington
Children's Hospital and Regional Medical Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Otsuka America Pharmaceutical
  More Information Identifier: NCT00048776     History of Changes
Other Study ID Numbers: 21-01-336 
Study First Received: November 7, 2002
Last Updated: July 14, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka America Pharmaceutical:
Secondary Raynaud's
mixed connective tissue disease

Additional relevant MeSH terms:
Raynaud Disease
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases processed this record on May 30, 2016