CRD007 for treatment of Abdominal Aorta Aneurysm. Version 1.0

• Research type

  Research Study

• Full title

  An international, multi-centre, randomised, stratified, double-blinded, placebo-controlled, 4-parallel group trial investigating the efficacy and safety of three different dose levels of CRD007 administered twice daily for 1 year to subjects with AAA (The AORTA trial)

• IRAS ID

  76404

• Contact name

  Matthew Thompson

• Sponsor organisation

  CARDOZ AB

• Eudract number

  2011-000285-35

• ISRCTN Number

  NA

• Research summary

  An abdominal aortic aneurysm is a dilation (swelling) of the large blood vessel (aorta) in the abdomen. The dilation can be caused by a local irritation (inflammation) in the vessel wall. That weakens the vessel wall structure. The aneurysm (the dilation) does not usually cause significant symptoms, but is likely to grow over time and the risk of rupture increases. Rupture can lead to severe bleeding and in some cases death. Currently, the only treatment is surgery. No medical treatment is available to treat abdominal aortic aneurysms (AAA).It is thought that specialised cells called mast cells play an important role in maintaining the local irritation (inflammation) in the vessel wall. By inhibiting the mast cells, further breakdown of the vessel wall may be stopped.The study medication CRD007 used in this study contains a substance called pemirolast, which is a mast cell inhibitor. This trial will investigate if CRD007 can stabilize the vessel wall and thereby slow down or prevent further growth of the aneurysm. The study will access 3 dosage levels of CRD007 (10mg, 25mg and 40mg) twice daily for 1 year. 300 female and male patients aged more or equal to 50 years with a diagnosis of AAA with a diameter between (or equal to) 39mm-49mm will be enrolled subject if satisfying all inclusion criterias an no exclusion criterias.Patients will be randomly assigned to one of the 3 dosages or to a placebo (inactive treatment). Patients will be required to visit the hospital a total of 7 times over the study period of approximately 55-57 weeks. During these visits patients will be required to give a full medical history, undergo physical examinations and ECG's (electrocardiograms), give blood and urine samples and undergo Ultrasound scanning of the aorta to measure the AAA diameter.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/0632

• Date of REC Opinion

  23 Jun 2011

• REC opinion

  Further Information Favourable Opinion