Abdominal Aortic AneurysmPhase 2NCT01354184
CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial)
A Phase 2 study testing CRD007 in people with Abdominal Aortic Aneurysm, run by RSPR Pharma AB at 15 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- CRD007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 15 sitesin 3 countries
- Study dates
- Start not givento not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Infra-renal abdominal aortic aneurysm
Who cannot join
- Previous infra-renal aortic surgery
- Known diabetes
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
Sweden8 sites
Borås Hospital, Department of Surgery
Borås, 501 82
Mälarsjukhuset, Team Kärl Kir. Klin.
Eskilstuna, 631 88
Sahlgrenska Universitetssjukhuset
Gothenburg, 413 45
Skånes Universitets Sjukhus, Institution of Surgical Science
Malmö, 205 02
Universitetssjukhuset Örebro, Kirurgkliniken, Kärlsektionen
Örebro, 701 85
Karolinska University Hospital, Kärlkirurgiska Kliniken
Stockholm, 171 76
Uppsala University Hospital
Uppsala, 751 85
Centrallaserettet, Kärlkirurgiska Kliniken
Västerås, 721-89
Denmark5 sites
Aalborg Hospital, Department of Vascular Surgery V
Aalborg, 9000
Aarhus Universitetshospital Skejby, Hjerte-Lunge-Kar kir. afd. T
Aarhus, 8200 N
Rigshospitalet, Karkirurgisk afdeling RK 3111
Copenhagen, 2100 Ø
Sygehus Lillebælt, Karkirurgisk Forskningsenhed
Kolding, 6000
Regionshospitalet Viborg, Karkiurgisk Forskningssektion
Viborg, 8800
United Kingdom2 sites
St George's Hospital NHS Trust
London, SW17 0Qt
University Hospital of South Manchester
Manchester, M23 9LT
About this study
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)
This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- CRD007, CRD007 matching placebo
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRD007Drug
CRD007 matching placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| CRD007 10 mg tablet | Experimental | Not described Receives: Drug: CRD007 |
| CRD007 25 mg tablet | Experimental | Not described Receives: Drug: CRD007 |
| CRD007 40 mg tablet | Experimental | Not described Receives: Drug: CRD007 |
| CRD007 matching placebo tablet | Placebo comparator | Not described Receives: Drug: CRD007 matching placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
Sponsor and investigators
- Lead sponsor
- RSPR Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henrik Sillesen, MD DMSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354184
- Sponsor's protocol ID
- Cardoz-003
- Status last verified
- Nov 2012
- First submitted
- 13 May 2011
- Last updated
- 6 Nov 2012
- Results posted
- No
Publications
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.
PubMed 25963302
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01354184
- Acronym / sponsor ID
- Cardoz-003
- Conditions
- Abdominal Aortic Aneurysm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- RSPR Pharma ABIndustry (pharma, biotech, devices)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigation of the efficacy and safety of CRD007 compared to placebo in the treatment of patients with abdominal aortic aneurysm.
Study design
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Infra-renal abdominal aortic aneurysm
Key exclusion criteria (2 listed)
- Previous infra-renal aortic surgery
- Known diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CRD007 | Drug | CRD007 10 mg tablet, CRD007 25 mg tablet, CRD007 40 mg tablet |
| CRD007 matching placebo | Drug | CRD007 matching placebo tablet |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Derived from this study: PubMed 25963302Sillesen 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.
Related trials for Abdominal Aortic Aneurysm
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Sillesen, MD DMSc principal investigator
Copenhagen University Hospital, Rigshospitalet
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRD007 in people with Abdominal Aortic Aneurysm, run by RSPR Pharma AB at 15 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Sweden, Denmark, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2012.