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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.

Sponsored by: Otsuka America Pharmaceutical
Information provided by: Otsuka America Pharmaceutical
ClinicalTrials.gov Identifier: NCT00048763
  Purpose

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.


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

MedlinePlus related topics:   Raynaud's Disease   

ChemIDplus related topics:   Cilostazol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Otsuka America Pharmaceutical:

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

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

Criteria

Inclusion critera:

  • 5 to 6 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048763

Locations
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
Schneider Children's Hospital    
      New Hyde Park, New York, United States, 11040
New York Medical College    
      Valhalla, New York, United States, 10595
Children's Hospital of Buffalo    
      Buffalo, New York, United States, 14222
United States, Ohio
Jobst Vascular Center    
      Toledo, Ohio, United States, 43606
United States, Pennsylvania
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

Study ID Numbers:   21-01-335
First Received:   November 7, 2002
Last Updated:   July 14, 2005
ClinicalTrials.gov Identifier:   NCT00048763
Health Authority:   United States: Food and Drug Administration

Keywords provided by Otsuka America Pharmaceutical:
circulatory  
vascular  
idiopathic  

Study placed in the following topic categories:
Cilostazol
Peripheral Vascular Diseases
Raynaud Disease
Vascular Diseases
Neoplasm Metastasis

Additional relevant MeSH terms:
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Protective Agents
Neuroprotective Agents
Pharmacologic Actions
Fibrin Modulating Agents
Phosphodiesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 05, 2008




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