Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048776
Status:
COMPLETED
Last Update Posted:
2005-07-19
First Post:
2002-11-07
Brief Title:
Safety and Efficacy of Pletal Cilostazol for the Treatment of Juvenile Primary and Secondary Raynauds Phenomenon
Sponsor:
Otsuka America Pharmaceutical
Organization:
Otsuka America Pharmaceutical
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Juvenile secondary Raynauds 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 Raynauds Phenomenon have an underlying condition such as systemic lupus scleroderma or mixed connective tissue disease When children with secondary Raynauds 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 andor turn purple or white The investigational drug Pletalcilostazol 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 Pletalcilostazol to lessen the severity of the symptoms and decrease the number of secondary Raynauds episodes in juvenile patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None