EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANTPhase 4NCT00190411
Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type
A Phase 4 study testing celiprolol in people with EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT and CHROMOSOME 2q31.2 DELETION SYNDROME, run by Assistance Publique - Hôpitaux de Paris.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT, CHROMOSOME 2q31.2 DELETION SYNDROME
- What is being tested?
- celiprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Oct 2003to Apr 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Proven disease,
- No betablocker at inclusion if previous CV event
Who cannot join
- 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
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- 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.
About this study
Official title: Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome
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
Read the 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.
- Being tested
- celiprolol, Control
- Keywords
- Arteries, ultrasonography, Ehlers Danlos syndrome, Cardiovascular disease, beta adrenergic antagonists
- Medical subject headings
- Ehlers-Danlos Syndrome, Type IV, Chromosome 2q31.2 Deletion Syndrome, Ehlers-Danlos Syndrome, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celiprololDrug
Also called celiprolol? Dose ranging 100 to 400 mg, dose adaptation, every 6 months by increment of 100 mg, based on tolerance
celiprolol
ControlDrug
Untreated controls excluding betablockers
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Celiprolol Receives: Drug: celiprolol; Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
Measured: during de study
Secondary outcomes (1)
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANTStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Pierre BOUTOUYRIE, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190411
- Sponsor's protocol ID
- P010309
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 16 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 20825986
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Vascular Complications by BetaBlocker Treatment in Vascular Ehlers-Danlos Syndrome
- ClinicalTrials.gov ID
- NCT00190411
- Acronym / sponsor ID
- P010309
- Keywords
- Arteries, ultrasonography, Ehlers Danlos syndrome, Cardiovascular disease, beta adrenergic antagonists
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Oct 2003
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: celiprolol, Drug: ControlCeliprolol |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Proven disease,
- No betablocker at inclusion if previous CV event
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celiprololAlso: celiprolol? Dose ranging 100 to 400 mg, dose adaptation, every 6 months by increment of 100 mg, based on toleranceceliprolol | Drug | Treatment |
| ControlUntreated controls excluding betablockers | Drug | Treatment |
Primary outcome
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
Time frame: during de study
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up
1 secondary outcome
Tolerance, effect of drug on arterial parameters : diameter, IMT, stiffness.
Time frame: during the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
- Derived from this study: PubMed 20825986Ong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre BOUTOUYRIE, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing celiprolol in people with EHLERS-DANLOS SYNDROME, TYPE IV, AUTOSOMAL DOMINANT and CHROMOSOME 2q31.2 DELETION SYNDROME, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in the rate of major cardiovascular events in the treated group during a 5 years follow-up (time frame: during de study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00190411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2013.