Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type

NCT00190411 ↗

Phase 4 Completed 54 enrolled Assistance Publique - Hôpitaux de Paris Aventis Pharmaceuticals · collab

RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start: 2003-10
Primary completion: 2011-04
Completion: 2011-04

Outcome

Met primary endpoint

paper The primary endpoints were reached by five (20%) in the celiprolol group and by 14 (50%) controls PMID 20825986 ↗

paper hazard ratio [HR] 0·36; 95% CI 0·15-0·88; p=0·040 PMID 20825986 ↗

Publications

Ong KT, Perdu J, De Backer J, Bozec E, Collignon P, Emmerich J, Fauret AL, Fiessinger JN, Germain DP, Georgesco G, Hulot JS, De Paepe A, Plauchu H, Jeunemaitre X, Laurent S, Boutouyrie P. Effect of celiprolol on prevention of cardiovascular events in vascular Ehlers-Danlos syndrome: a prospective randomised, open, blinded-endpoints trial. Lancet. 2010 Oct 30;376(9751):1476-84. doi: 10.1016/S0140-6736(10)60960-9. Epub 2010 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Celiprolol	Small molecule	400 mg	—