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| Sponsor: | Otsuka America Pharmaceutical |
|---|---|
| Information provided by: | Otsuka America Pharmaceutical |
| ClinicalTrials.gov Identifier: | NCT00048776 |
Purpose
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Eligibility| Ages Eligible for Study: | 5 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
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 | |
| Children's Hospital of Buffalo | |
| Buffalo, New York, United States, 14222 | |
| New York Medical College | |
| Valhalla, New York, United States, 10595 | |
| Schneider Children's Hospital | |
| New Hyde Park, New York, United States, 11040 | |
| SUNY Downstate Medical Center | |
| Brooklyn, New York, United States, 11203 | |
| 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 | |
| Altoona Center for Clinical Research | |
| Duncansville, Pennsylvania, United States, 16635 | |
| 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
| Study ID Numbers: | 21-01-336 |
| Study First Received: | November 7, 2002 |
| Last Updated: | July 14, 2005 |
| ClinicalTrials.gov Identifier: | NCT00048776 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Secondary Raynaud's circulatory vascular |
scleroderma lupus mixed connective tissue disease |
|
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Neuroprotective Agents Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases Cilostazol Peripheral Vascular Diseases Raynaud Disease |
Vascular Diseases Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Phosphodiesterase Inhibitors Autonomic Agents Platelet Aggregation Inhibitors Peripheral Nervous System Agents Bronchodilator Agents Central Nervous System Agents |