CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)

This study has been completed.
Sponsor:
Information provided by:
Cardoz AB
ClinicalTrials.gov Identifier:
NCT01354184
First received: May 13, 2011
Last updated: November 5, 2012
Last verified: November 2012
  Purpose

This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.


Condition Intervention Phase
Abdominal Aortic Aneurysm
Drug: CRD007
Drug: CRD007 matching placebo
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Cardoz AB:

Arms Assigned Interventions
Experimental: CRD007 10 mg tablet Drug: CRD007
Experimental: CRD007 25 mg tablet Drug: CRD007
Experimental: CRD007 40 mg tablet Drug: CRD007
Placebo Comparator: CRD007 matching placebo tablet Drug: CRD007 matching placebo

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Infra-renal abdominal aortic aneurysm

Exclusion Criteria:

  • Previous infra-renal aortic surgery
  • Known diabetes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354184

Locations
Denmark
Aalborg Hospital, Department of Vascular Surgery V
Aalborg, Denmark, 9000
Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T
Aarhus, Denmark, 8200 N
Rigshospitalet, Karkirurgisk afdeling RK 3111
Copenhagen, Denmark, 2100 Ø
Sygehus Lillebælt, Karkirurgisk Forskningsenhed
Kolding, Denmark, 6000
Regionshospitalet Viborg, Karkiurgisk Forskningssektion
Viborg, Denmark, 8800
Sweden
Borås Hospital, Department of Surgery
Borås, Sweden, 501 82
Mälarsjukhuset, Team Kärl Kir. Klin.
Eskilstuna, Sweden, 631 88
Sahlgrenska Universitetssjukhuset
Göteborg, Sweden, 413 45
Skånes Universitets Sjukhus, Institution of Surgical Science
Malmo, Sweden, 205 02
Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen
Orebro, Sweden, 701 85
Karolinska University Hospital, Kärlkirurgiska Kliniken
Stockholm, Sweden, 171 76
Uppsala University Hospital
Uppsala, Sweden, 751 85
Centrallaserettet, Kärlkirurgiska Kliniken
Västerås, Sweden, 721-89
United Kingdom
St George's Hospital NHS Trust
London, United Kingdom, SW17 0Qt
University Hospital of South Manchester
Manchester, United Kingdom, M23 9LT
Sponsors and Collaborators
Cardoz AB
Investigators
Principal Investigator: Henrik Sillesen, MD DMSc Rigshospitalet, University of Copenhagen, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01354184     History of Changes
Other Study ID Numbers: Cardoz-003
Study First Received: May 13, 2011
Last Updated: November 5, 2012
Health Authority: Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on October 01, 2014