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

NCT ID: NCT01354184

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Groups

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CRD007 10 mg tablet

Group Type EXPERIMENTAL

CRD007

Intervention Type DRUG

CRD007 25 mg tablet

Group Type EXPERIMENTAL

CRD007

Intervention Type DRUG

CRD007 40 mg tablet

Group Type EXPERIMENTAL

CRD007

Intervention Type DRUG

CRD007 matching placebo tablet

Group Type PLACEBO_COMPARATOR

CRD007 matching placebo

Intervention Type DRUG

Interventions

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CRD007

Intervention Type DRUG

CRD007 matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Infra-renal abdominal aortic aneurysm

Exclusion Criteria

* Previous infra-renal aortic surgery
* Known diabetes
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RSPR Pharma AB

INDUSTRY

Sponsor Role lead

Principal Investigators

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Henrik Sillesen, MD DMSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, University of Copenhagen, Denmark

Locations

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Aalborg Hospital, Department of Vascular Surgery V

Aalborg, , Denmark

Site Status

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

Aarhus, , Denmark

Site Status

Rigshospitalet, Karkirurgisk afdeling RK 3111

Copenhagen, , Denmark

Site Status

Sygehus Lillebælt, Karkirurgisk Forskningsenhed

Kolding, , Denmark

Site Status

Regionshospitalet Viborg, Karkiurgisk Forskningssektion

Viborg, , Denmark

Site Status

Borås Hospital, Department of Surgery

Borås, , Sweden

Site Status

Mälarsjukhuset, Team Kärl Kir. Klin.

Eskilstuna, , Sweden

Site Status

Sahlgrenska Universitetssjukhuset

Gothenburg, , Sweden

Site Status

Skånes Universitets Sjukhus, Institution of Surgical Science

Malmo, , Sweden

Site Status

Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen

Örebro, , Sweden

Site Status

Karolinska University Hospital, Kärlkirurgiska Kliniken

Stockholm, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Centrallaserettet, Kärlkirurgiska Kliniken

Västerås, , Sweden

Site Status

St George's Hospital NHS Trust

London, , United Kingdom

Site Status

University Hospital of South Manchester

Manchester, , United Kingdom

Site Status

Countries

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Denmark Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25963302 (View on PubMed)

Other Identifiers

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Cardoz-003

Identifier Type: -

Identifier Source: org_study_id