Safety and Efficacy of Pletal(Cilostazol) for the Treatment of Juvenile Primary and Secondary Raynaud’s Phenomenon
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion critera:
- 5 to 6 years old
- fulfill diagnostic criteria for primary or secondary Raynaud's
Contacts and 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 | |
| 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 | |
| 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 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00048763 History of Changes |
| Other Study ID Numbers: | 21-01-335 |
| 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:
|
circulatory vascular idiopathic |
Additional relevant MeSH terms:
|
Raynaud Disease Peripheral Vascular Diseases Vascular Diseases Cardiovascular Diseases Cilostazol Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors |
Vasodilator Agents Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Phosphodiesterase 3 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 19, 2013