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NCT01354184 Clinical Trial

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

Abdominal Aortic Aneurysm Clinical 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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01354184
Other study ID # Cardoz-003
Secondary ID
Status Completed
Phase Phase 2
First received May 13, 2011
Last updated November 5, 2012

Study information
Verified date November 2012
Source RSPR Pharma AB
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines AgencySweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Infra-renal abdominal aortic aneurysm

Exclusion Criteria:

- Previous infra-renal aortic surgery

- Known diabetes

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• CRD007

• CRD007 matching placebo

Locations
Country Name City State
Denmark Aalborg Hospital, Department of Vascular Surgery V Aalborg
Denmark Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T Aarhus
Denmark Rigshospitalet, Karkirurgisk afdeling RK 3111 Copenhagen
Denmark Sygehus Lillebælt, Karkirurgisk Forskningsenhed Kolding
Denmark Regionshospitalet Viborg, Karkiurgisk Forskningssektion Viborg
Sweden Borås Hospital, Department of Surgery Borås
Sweden Mälarsjukhuset, Team Kärl Kir. Klin. Eskilstuna
Sweden Sahlgrenska Universitetssjukhuset Göteborg
Sweden Skånes Universitets Sjukhus, Institution of Surgical Science Malmo
Sweden Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen Orebro
Sweden Karolinska University Hospital, Kärlkirurgiska Kliniken Stockholm
Sweden Uppsala University Hospital Uppsala
Sweden Centrallaserettet, Kärlkirurgiska Kliniken Västerås
United Kingdom St George's Hospital NHS Trust London
United Kingdom University Hospital of South Manchester Manchester

Sponsors (1)
Lead Sponsor Collaborator
RSPR Pharma AB

Countries where clinical trial is conducted

Denmark,  Sweden,  United Kingdom, 

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