|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type | ||||
| Official Title † | Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome | ||||
| 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 BID)or 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 Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up | ||||
| Secondary Outcome Measure † | Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness. | ||||
| Condition † | Ehlers-Danlos Syndrome, Type Iv, Autosomal Dominant Gene Map Locus 2q31 |
||||
| Intervention † | Drug: celiprolol | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 100 | ||||
| Start Date † | October 2003 | ||||
| Completion Date | October 2010 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion criteria: Criteria of not inclusion for the RIGHTEOUS group:
Criteria of not inclusion for both groups:
|
||||
| Gender | Both | ||||
| Ages | 15 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | France | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00190411 | ||||
| Organization ID | AOM 01108 | ||||
| Secondary IDs †† | P010309 | ||||
| Study Sponsor † | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators †† | Aventis Pharmaceuticals | ||||
| Investigators † |
|
||||
| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | March 2007 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | March 13, 2007 | ||||