Abdominal aortic aneurysm (AAA) is a dilatation of the aorta as it passes through the abdomen, defined as a dilatation of the infra-renal aorta to a diameter of 30 mm. AAA is generally asymptomatic and the greatest concern is the risk of rupture, which causes severe pain, massive internal hemorrhage, and, without prompt treatment, death. MedDRA version: 14.1 Level: LLT Classification code 10000054 Term: Abdominal aortic aneurysm System Organ Class: 10047065 - Vascular disorders
Conditions
Sponsors
Cardoz AB
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the optimal oral dose of CRD007 (10 mg, 25 mg and 40 mg tablets) in comparison to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 12 months of treatment (b.i.d.) as assessed by measurement method A (based on measurement perfromed during systole).;Secondary Objective: • To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 12 months of treatment (b.i.d.) as assessed by measurement method A (based on measurement performed during diastole) - To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 12 months of treatment (b.i.d.) as assessed by measurement method B • To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of change in maximum aortic diameter after 6 months of treatment (b.i.d.) as assessed by measurement method A and B • To compare CRD007 (10 mg, 25 mg and 40 mg tablets) to matching placebo tablets with respect to efficacy in terms of incidence and time to maximum aortic diameter of 50 mm as assessed by measurement method A and B;Primary end point(s): Absolute change in maximum aortic diameter from screening (Visit 1) to 12 months of treatment (Visit 7) as assessed by measurement method A.;Timepoint(s) of evaluation of this end point: The primary endpoint is evaluated after 12 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Absolute change in maximum aortic diameter from screening (Visit 1) to 12 months of treatment (Visit 7) as assessed by measurement method B3 • Absolute change in maximum aortic diameter from screening (Visit 1) to 6 months of treatment (Visit 5) as assessed by both measurement method A and B3 • Incidence and time to maximum aortic diameter of 50 mm as assessed by measurement method A and B3 • Incidence and time to clinical events of special interest - Acute or elective aneurysm repair - Aneurysm rupture - Major cardiovascular events - Other clinical events of special interest - Death (any cause) • Biomarkers • Adverse events • ECG assessments • Blood pressure and pulse • Haematology, serum chemistry and liver function parameters;Timepoint(s) of evaluation of this end point: •The evaluation of change in maximum aortic diameter after 6 and 12 months of treatment • Incidencee and time to clinical event: any time during the treatment • Biomarkers: after 12 months treatment • Adverse events: at each clinical visit (week 1, 13, 26, 39 and 52 of treatment) • ECG assessment: after 12 months treatment • Blood pressure and pulse: at each clinical visit (week 1, 13, 26, 39 and 52 of treatment) • Haematology, serum chemistry and liver function parameters: after 13, 26, 39 and 52 weeks treatment | — |
Countries
Denmark, Sweden, United Kingdom
Contacts
Public ContactCEO
Cardoz AB
Outcome results
None listed