NCT01354184

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

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
Last Updated

November 6, 2012

Status Verified

November 1, 2012

First QC Date

May 13, 2011

Last Update Submit

November 5, 2012

Conditions

Abdominal Aortic Aneurysm

Study Arms (4)

CRD007 10 mg tablet

EXPERIMENTAL
Drug: CRD007

CRD007 25 mg tablet

EXPERIMENTAL
Drug: CRD007

CRD007 40 mg tablet

EXPERIMENTAL
Drug: CRD007

CRD007 matching placebo tablet

PLACEBO COMPARATOR
Drug: CRD007 matching placebo

Interventions

CRD007DRUG
CRD007 10 mg tabletCRD007 25 mg tabletCRD007 40 mg tablet
CRD007 matching placeboDRUG
CRD007 matching placebo tablet

Eligibility Criteria

Age50 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (15)

Aalborg Hospital, Department of Vascular Surgery V

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T

Aarhus, 8200 N, Denmark

Location

Rigshospitalet, Karkirurgisk afdeling RK 3111

Copenhagen, 2100 Ø, Denmark

Location

Sygehus Lillebælt, Karkirurgisk Forskningsenhed

Kolding, 6000, Denmark

Location

Regionshospitalet Viborg, Karkiurgisk Forskningssektion

Viborg, 8800, Denmark

Location

Borås Hospital, Department of Surgery

Borås, 501 82, Sweden

Location

Mälarsjukhuset, Team Kärl Kir. Klin.

Eskilstuna, 631 88, Sweden

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 413 45, Sweden

Location

Skånes Universitets Sjukhus, Institution of Surgical Science

Malmo, 205 02, Sweden

Location

Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen

Örebro, 701 85, Sweden

Location

Karolinska University Hospital, Kärlkirurgiska Kliniken

Stockholm, 171 76, Sweden

Location

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Centrallaserettet, Kärlkirurgiska Kliniken

Västerås, 721-89, Sweden

Location

St George's Hospital NHS Trust

London, SW17 0Qt, United Kingdom

Location

University Hospital of South Manchester

Manchester, M23 9LT, United Kingdom

Location

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

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Henrik Sillesen, MD DMSc

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 16, 2011

Last Updated

November 6, 2012

Record last verified: 2012-11

Locations

GB(2)DK(5)SE(8)