Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00190411
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2005-09-13
Brief Title:
Celiprolol in Patients With Ehlers-Danlos Syndrome Vascular Type
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ehlers-Danlos syndrome vascular type EDS-IV is caused by a genetic defect of collagen type III Patient die median 40 yrs of vascular complications There is no treatment We showed that arteries are thin and overloaded in this patients We test the protective effect of celiprolol on cardiovascular events in a 5 years randomized PROBE design
Detailed Description:
100 patients with verified EDS-IV syndrome are included Patients are randomized to either celiprolol 50 to 400 mg BIDor no treatment Patients who are not randomized enter a longitudinal survey of events The hypothesis is a 50 reduction in the occurrence of cardiovascular events under treatment assessed by a blinded independent events committee
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