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

NCT ID: NCT00048776

Last Updated: 2005-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Raynaud's Disease

Keywords

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Secondary Raynaud's circulatory vascular scleroderma lupus mixed connective tissue disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pletal

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 5 to 16 years old
* fulfill diagnostic criteria for primary or secondary Raynaud's
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka America Pharmaceutical

INDUSTRY

Sponsor Role lead

Locations

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Advanced Medical Clinical Therapeutics

Anchorage, Alaska, United States

Site Status

Advanced Medical Research Institute

Fresno, California, United States

Site Status

Madera Family Medical Group

Madera, California, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

LaRabida Children's Hospital

Chicago, Illinois, United States

Site Status

Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

St. Louis University Health Sciences Center

St Louis, Missouri, United States

Site Status

Children's Hospital

Omaha, Nebraska, United States

Site Status

Asthma & Allergy Research Center

Newark, New Jersey, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Children's Hospital of Buffalo

Buffalo, New York, United States

Site Status

Schneider Children's Hospital

New Hyde Park, New York, United States

Site Status

New York Medical College

Valhalla, New York, United States

Site Status

Jobst Vascular Center

Toledo, Ohio, United States

Site Status

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status

The Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Monarch Research Associates

Norfolk, Virginia, United States

Site Status

Children's Hospital and Regional Medical Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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21-01-336

Identifier Type: -

Identifier Source: org_study_id