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

November 5, 2012 updated by: RSPR Pharma AB

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infra-renal abdominal aortic aneurysm

Exclusion Criteria:

  • Previous infra-renal aortic surgery
  • Known diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RSPR Pharma AB

Investigators

  • Principal Investigator: Henrik Sillesen, MD DMSc, Rigshospitalet, University of Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 13, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 16, 2011

Study Record Updates

Last Update Posted (Estimate)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cardoz-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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