CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)
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 (The AORTA Trial)
1 other identifier
interventional
N/A
3 countries
15
Brief Summary
This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 16, 2011
CompletedNovember 6, 2012
November 1, 2012
May 13, 2011
November 5, 2012
Conditions
Study Arms (4)
CRD007 10 mg tablet
EXPERIMENTALCRD007 25 mg tablet
EXPERIMENTALCRD007 40 mg tablet
EXPERIMENTALCRD007 matching placebo tablet
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Infra-renal abdominal aortic aneurysm
You may not qualify if:
- Previous infra-renal aortic surgery
- Known diabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RSPR Pharma ABlead
Study Sites (15)
Aalborg Hospital, Department of Vascular Surgery V
Aalborg, 9000, Denmark
Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T
Aarhus, 8200 N, Denmark
Rigshospitalet, Karkirurgisk afdeling RK 3111
Copenhagen, 2100 Ø, Denmark
Sygehus Lillebælt, Karkirurgisk Forskningsenhed
Kolding, 6000, Denmark
Regionshospitalet Viborg, Karkiurgisk Forskningssektion
Viborg, 8800, Denmark
Borås Hospital, Department of Surgery
Borås, 501 82, Sweden
Mälarsjukhuset, Team Kärl Kir. Klin.
Eskilstuna, 631 88, Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45, Sweden
Skånes Universitets Sjukhus, Institution of Surgical Science
Malmo, 205 02, Sweden
Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen
Örebro, 701 85, Sweden
Karolinska University Hospital, Kärlkirurgiska Kliniken
Stockholm, 171 76, Sweden
Uppsala University Hospital
Uppsala, 751 85, Sweden
Centrallaserettet, Kärlkirurgiska Kliniken
Västerås, 721-89, Sweden
St George's Hospital NHS Trust
London, SW17 0Qt, United Kingdom
University Hospital of South Manchester
Manchester, M23 9LT, United Kingdom
Related Publications (1)
Sillesen H, Eldrup N, Hultgren R, Lindeman J, Bredahl K, Thompson M, Wanhainen A, Wingren U, Swedenborg J; AORTA Trial Investigators. Randomized clinical trial of mast cell inhibition in patients with a medium-sized abdominal aortic aneurysm. Br J Surg. 2015 Jul;102(8):894-901. doi: 10.1002/bjs.9824. Epub 2015 May 12.
PMID: 25963302DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Sillesen, MD DMSc
Rigshospitalet, Denmark