EUCTR2011-000285-35-DKActive, not recruitingNot Applicable
An international, multi-centre, randomised, stratified, double-blinded,placebo-controlled, 4-parallel group trial investigating the efficacy and safetyof three different dose levels of CRD007 administered twice daily for 1 yearto subjects with AAA (The AORTA trial). - CRD007 for the treatment of AAA
Cardoz AB0 sites300 target enrollmentStarted: April 15, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Infrarenal abdominal aortic aneurysm with a maximum diameter between =39 mm and
- •2. Age =50 years
- •3. Following receipt of verbal and written information about the trial, the subject has
- •provided signed informed consent before any trial related activity is carried out
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
Exclusion Criteria
- •1. Previous infra-renal aortic surgery
- •2. Planned major surgery
- •3. Known aortic dissection
- •4. Known diabetes
- •5. Treatment with systemic corticosteroids or any other systemic immunomodulatory therapy
- •6. Known or suspected inherited connective tissue disorders (i.e. Marfan or Vascular Ehlers
- •Danlos syndrome)
- •7. Calculated CLCR < 30 ml/min5
- •8. Known significant liver disease (e.g. acute clinical hepatitis, chronic active hepatitis or
- •ALT >3 x the ULN6)
- •9. Known HIV infection at the time of screening
- •10. Serious concomitant illness associated with a life expectancy less than 2 years
- •11. Active severe infection, any other concurrent disease or medical conditions that are
- •deemed to interfere with the conduct of the trial as judged by the investigator
- •12. Clinically significant cardiac disease including unstable angina, acute myocardial
- •infarction within six months from screening and congestive heart failure (NYHA III-IV
- •according to the New York Heart Association (NYHA) functional classification system)
- •13. Significant concurrent, uncontrolled medical condition including, but not limited to, renal,
- •hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
- •psychiatric disease evaluated by the investigator to interfere with effect of the trial drug
- •14. Subjects known or suspected of not being able to comply with this trial protocol (e.g. due
- •to alcoholism, drug dependency or psychological disorder)
- •15. Receipt of prior experimental agents within 30 days prior to screening
- •16. Current participation in any other interventional clinical trial
- •17. Subjects with known uncontrolled allergic conditions or allergy/hypersensitivity to any
- •component of the trial drug or placebo excipients
Investigators
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