Behcet's DiseaseNCT04328064
The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
A study testing Rosuvastatin calcium 40mg in people with Behcet's Disease, run by University of Alexandria.
Trial summary
Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. Read more about this study
- Who is it for?
- Ages 17 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behcet's Disease
- What is being tested?
- Rosuvastatin calcium 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jun 2011
- Phase
- Interventional
- 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 17 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all patients fulfilling the classification criteria of the International Study Group for Behçet's disease
Who cannot join
- smoking,
- diabetes mellitus,
- hypercholesterolaemia,
- hypertension,
- cardiac insufficiency,
- coexisting hepatic and renal diseases
- inflammatory diseases.
About this study
Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups.
The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.
- Conditions
- Behcet's Disease
- Being tested
- Rosuvastatin calcium 40mg, Placebo oral tablet
- Keywords
- Behcet's Disease, Rosuvastatin, Vascular Markers, Improvement in vascular involvement in Behcet's Disease
- Medical subject headings
- Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin calcium 40mgDrug
Also called Experimental active drug
Active drug -Rosuvastatin
Placebo oral tabletDrug
Also called Placebo comparator
40 mg placebo for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin Drug | Active comparator | Active drug-rosuvastatin 40 mg Receives: Drug: Rosuvastatin calcium 40mg; Drug: Placebo oral tablet |
| Placebo drug | Placebo comparator | Placebo oral tablet Receives: Drug: Rosuvastatin calcium 40mg; Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in endothelial and vascular inflammatory markers
Outcome measures included alterations in endothelial injury and vascular inflammatory markers.
Measured: 12 months
Secondary outcomes (1)
Occurrence of new-onset vascular involvement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study startMay 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's DiseaseStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Abou-Raya, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328064
- Sponsor's protocol ID
- alexmed116619312
- Status last verified
- Mar 2020
- First submitted
- 29 Aug 2011
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
- ClinicalTrials.gov ID
- NCT04328064
- Acronym / sponsor ID
- alexmed116619312
- Conditions
- Behcet's Disease
- Keywords
- Behcet's Disease, Rosuvastatin, Vascular Markers, Improvement in vascular involvement in Behcet's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 31 Mar 2020 (actual)
- 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.
Behçet's Disease(BD) is a systemic inflammatory vasculitis, which affects all types and sizes of vessels. Statins display numerous effects often independent of the well-established lipid-lowering effects that may be of benefit in retarding or preventing vascular injury and ischaemic vascular events. The aim of the present study was to determine the efficacy of rosuvastatin in improving vascular dysfunction and vascular inflammation and to assess the effect of rosuvastatin on vascular involvement in BD patients. Fifty-six BD patients (51 males and 5 females) mean age 33.4 years, mean disease duration 5.8 years), all fulfilling the classification criteria of the International Study Group for Behçet's disease were recruited.Patients were randomised into 2 groups.
The first group (n=27: 20 active and 7 inactive) were assigned to receive 40 mg of rosuvastatin and the second group(n=29: 21 active and 8 inactive) received placebo for 12 months. Inflammatory and endothelial dysregulation markers were measured at baseline and after 12 months. All patients were examined for vascular involvement. Venous or arterial system involvement was defined as present when confirmed by Doppler ultrasonography, magnetic resonance angiography, conventional angiography or CT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin Drug | Active comparator | Drug: Rosuvastatin calcium 40mg, Drug: Placebo oral tabletActive drug-rosuvastatin 40 mg |
| Placebo drug | Placebo comparator | Drug: Rosuvastatin calcium 40mg, Drug: Placebo oral tabletPlacebo oral tablet |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients fulfilling the classification criteria of the International Study Group for Behçet's disease
Key exclusion criteria (7 listed)
- smoking,
- diabetes mellitus,
- hypercholesterolaemia,
- hypertension,
- cardiac insufficiency,
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 |
|---|---|---|
| Rosuvastatin calcium 40mgAlso: Experimental active drugActive drug -Rosuvastatin | Drug | Placebo drug, Rosuvastatin Drug |
| Placebo oral tabletAlso: Placebo comparator40 mg placebo for 12 months | Drug | Placebo drug, Rosuvastatin Drug |
Primary outcome
Changes in endothelial and vascular inflammatory markers
Time frame: 12 months
Outcome measures included alterations in endothelial injury and vascular inflammatory markers.
1 secondary outcome
Occurrence of new-onset vascular involvement
Time frame: 6 months
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 31 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin calcium 40mg in people with Behcet's Disease, run by University of Alexandria.
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 1 inclusion and 7 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 31 Mar 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Changes in endothelial and vascular inflammatory markers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2020.