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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Collaborator: |
Aventis Pharmaceuticals |
| Information provided by: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00190411 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Ehlers-Danlos Syndrome, Type Iv, Autosomal Dominant Gene Map Locus 2q31 |
Drug: celiprolol |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | October 2010 |
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.
Eligibility| Ages Eligible for Study: | 15 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Criteria of not inclusion for the RIGHTEOUS group:
Criteria of not inclusion for both groups:
Contacts and Locations| France | |
| Clinical Pharmacology Unit, HEGP, AP-HP | |
| Paris, France, 75015 | |
| Principal Investigator: | Pierre BOUTOUYRIE, MD,PhD | Assistance Publique - Hôpitaux de Paris |
More Information
| Study ID Numbers: | AOM 01108, P010309 |
| Study First Received: | September 13, 2005 |
| Last Updated: | March 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00190411 History of Changes |
| Health Authority: | France: Ministry of Health |
|
Arteries ultrasonography Ehlers Danlos syndrome Cardiovascular disease beta adrenergic antagonists |
|
Vasodilator Agents Neurotransmitter Agents Ehlers-Danlos Syndrome Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hemostatic Disorders Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Syndrome Connective Tissue Diseases Adrenergic beta-Antagonists Cardiovascular Diseases Anti-Arrhythmia Agents |
Congenital Abnormalities Skin Diseases, Genetic Sympatholytics Disease Collagen Diseases Skin Diseases Celiprolol Hematologic Diseases Skin Abnormalities Vascular Diseases Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Genetic Diseases, Inborn Autonomic Agents |