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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT04328064
Date of registration: 29/08/2011
Prospective Registration: No
Primary sponsor: University of Alexandria
Public title: The Role of Rosuvastatin on Vascular Involvement in Behçet's Disease
Scientific title:
Date of first enrolment: May 2010
Target sample size: 56
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- all patients fulfilling the classification criteria of the International Study Group
for Behçet's disease

Exclusion Criteria:

- smoking,

- diabetes mellitus,

- hypercholesterolaemia,

- hypertension,

- cardiac insufficiency,

- coexisting hepatic and renal diseases

- inflammatory diseases.

Age minimum: 17 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Behcet's Disease
Drug: Placebo oral tablet
Drug: Rosuvastatin calcium 40mg
Primary Outcome(s)
Changes in endothelial and vascular inflammatory markers [Time Frame: 12 months]
Secondary Outcome(s)
Occurrence of new-onset vascular involvement [Time Frame: 6 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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