Status:
COMPLETED
Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT
CHROMOSOME 2q31.2 DELETION SYNDROME
Eligibility:
All Genders
15-65 years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Proven disease,
- No betablocker at inclusion if previous CV event
- Exclusion criteria:
- Criteria of not inclusion for the RIGHTEOUS group:
- Patient having already presented an arterial break or a dissection and treated(handled) by bétâ-blocking(surrounding).
- Against indication in the use of CELIPROLOL:
- Unchecked cardiac insufficiency by the treatment
- cardiogenic shock
- BAV of 2nd and 3rd not sailed degrees
- angor of Prinzmetal
- disease of the sine
- bradycardia
- pheochromocytoma untreated
- low blood pressure
- sentimentality in the CELIPROLOL
- Antecedent of anaphylactic reaction
- myasthenia
- treatment by FLOCTAFENINE ( Idarac), Sultopride ( interactions ) In these two cases, the patient can be included in the group followed by troop.
- Criteria of not inclusion for both groups:
- Refusal to participate in the study.
- Impossibility to move.
- Pregnancy
- Woman in age to procreate without means of effective contraception.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00190411
Start Date
October 1 2003
End Date
April 1 2011
Last Update
January 16 2013
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