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OpenTrials
Completed

NCT Number: NCT00048776

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

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.

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Key information

Age range

5 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Advanced Medical Clinical Therapeutics, Anchorage, Alaska, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 5 to 16 years old
  • fulfill diagnostic criteria for primary or secondary Raynaud's

Treatment and study plan

Pletal

Drug

Sponsors and collaborators

Lead sponsor

Otsuka America Pharmaceutical

Industry

Registry information

Important dates

Study start
2001
Study completion
2003
First posted
Nov 11, 2002
Registry last updated
Jul 19, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.