An international multi-centre one-year trial of effects and side-effects of CRD007 tablets for treatment of aneurysm (dilation) of the aorta (the largest artery in the body) in the abdominal cavity.

• Conditions: Abdominal aortic aneurysm (AAA) is a dilatation of the aorta as it passes through theabdomen, defined as a dilatation of the infra-renal aorta to a diameter of 30 mm. AAA isgenerally asymptomatic and the greatest concern is the risk of rupture, which causes severepain, massive internal hemorrhage, and, without prompt treatment, death.; MedDRA version: 13.1Level: LLTClassification code 10000054Term: Abdominal aortic aneurysmSystem Organ Class: 10047065 - Vascular disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-000285-35-GB
• Lead Sponsor: Cardoz AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-24
• Last Update Posted: 5 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Infrarenal abdominal aortic aneurysm with a maximum diameter between =39 mm and
=49 mm4
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified