Back to resultsCRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CRD007
CRD007 matching placebo
Sponsored by
About this trial
This is an interventional trial for Abdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria:
- Infra-renal abdominal aortic aneurysm
Exclusion Criteria:
- Previous infra-renal aortic surgery
- Known diabetes
Sites / Locations
- Aalborg Hospital, Department of Vascular Surgery V
- Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T
- Rigshospitalet, Karkirurgisk afdeling RK 3111
- Sygehus Lillebælt, Karkirurgisk Forskningsenhed
- Regionshospitalet Viborg, Karkiurgisk Forskningssektion
- Borås Hospital, Department of Surgery
- Mälarsjukhuset, Team Kärl Kir. Klin.
- Sahlgrenska Universitetssjukhuset
- Skånes Universitets Sjukhus, Institution of Surgical Science
- Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen
- Karolinska University Hospital, Kärlkirurgiska Kliniken
- Uppsala University Hospital
- Centrallaserettet, Kärlkirurgiska Kliniken
- St George's Hospital NHS Trust
- University Hospital of South Manchester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
CRD007 10 mg tablet
CRD007 25 mg tablet
CRD007 40 mg tablet
CRD007 matching placebo tablet
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01354184
Brief Title
CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)
Official 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 (The AORTA Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
RSPR Pharma AB
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Study Phase
Phase 2
8. Arms, Groups, and Interventions
Arm Title
CRD007 10 mg tablet
Arm Type
Experimental
Arm Title
CRD007 25 mg tablet
Arm Type
Experimental
Arm Title
CRD007 40 mg tablet
Arm Type
Experimental
Arm Title
CRD007 matching placebo tablet
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CRD007
Intervention Type
Drug
Intervention Name(s)
CRD007 matching placebo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Eligibility Criteria
Inclusion Criteria:
Infra-renal abdominal aortic aneurysm
Exclusion Criteria:
Previous infra-renal aortic surgery
Known diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Sillesen, MD DMSc
Organizational Affiliation
Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg Hospital, Department of Vascular Surgery V
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T
City
Aarhus
ZIP/Postal Code
8200 N
Country
Denmark
Facility Name
Rigshospitalet, Karkirurgisk afdeling RK 3111
City
Copenhagen
ZIP/Postal Code
2100 Ø
Country
Denmark
Facility Name
Sygehus Lillebælt, Karkirurgisk Forskningsenhed
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Regionshospitalet Viborg, Karkiurgisk Forskningssektion
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
Facility Name
Borås Hospital, Department of Surgery
City
Borås
ZIP/Postal Code
501 82
Country
Sweden
Facility Name
Mälarsjukhuset, Team Kärl Kir. Klin.
City
Eskilstuna
ZIP/Postal Code
631 88
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Skånes Universitets Sjukhus, Institution of Surgical Science
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Karolinska University Hospital, Kärlkirurgiska Kliniken
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Centrallaserettet, Kärlkirurgiska Kliniken
City
Västerås
ZIP/Postal Code
721-89
Country
Sweden
Facility Name
St George's Hospital NHS Trust
City
London
ZIP/Postal Code
SW17 0Qt
Country
United Kingdom
Facility Name
University Hospital of South Manchester
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
25963302
Citation
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. Erratum In: Br J Surg. 2015 Sep;102(10):1295. Br J Surg. 2016 Feb;103(3):308.
Results Reference
derived
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CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)
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