Arterial Occlusive DiseasePhase 4NCT00447889
A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR) Angiography
A Phase 4 study testing gadoteric acid in people with Arterial Occlusive Disease, run by Guerbet at 1 site in South Korea.
Trial summary
This is a clinical study of gadoteric acid in non-coronary MR angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Occlusive Disease
- What is being tested?
- gadoteric acid
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2006to Nov 2007
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least the age of legal maturity
- Strongly suspected of having non-coronary arterial disease, detected clinically
- Scheduled to undergo x-ray angiography examination
- Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
- Females of childbearing potential must have a documented negative urine pregnancy test.
Who cannot join
- Contraindication to magnetic resonance imaging (MRI)
- Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
- Congenital morphologic vascular abnormalities
- Known allergy to gadolinium chelates
- Pregnant, breast feeding, or planning to become pregnant during the trial
- Received a gadolinium complex within 2 days or iron oxide nanoparticles within 7 days before the gadoteric acid-enhanced magnetic resonance angiography (MRA) examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
This is a clinical study of gadoteric acid in non-coronary MR angiography.
- Conditions
- Arterial Occlusive Disease
- Being tested
- gadoteric acid
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadoteric acidDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2007 (estimated)
- Study startMar 2006
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial Occlusive DiseaseStudies 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 4
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Corinne Dubourdieu, PhD, Study chair, Guerbet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447889
- Sponsor's protocol ID
- DGD-44-042
- Status last verified
- Nov 2008
- First submitted
- 14 Mar 2007
- Last updated
- 26 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Gadoteric Acid in Non-Coronary Magnetic Resonance (MR)
- ClinicalTrials.gov ID
- NCT00447889
- Acronym / sponsor ID
- DGD-44-042
- Conditions
- Arterial Occlusive Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 15 Mar 2007 (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 a clinical study of gadoteric acid in non-coronary MR angiography.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, at least the age of legal maturity
- Strongly suspected of having non-coronary arterial disease, detected clinically
- Scheduled to undergo x-ray angiography examination
- Female patients must be using effective contraception or be surgically sterilized or post-menopausal.
- Females of childbearing potential must have a documented negative urine pregnancy test.
Key exclusion criteria (6 listed)
- Contraindication to magnetic resonance imaging (MRI)
- Any metallic medical device in the vascular territory for which the patient is to undergo imaging examinations
- Congenital morphologic vascular abnormalities
- Known allergy to gadolinium chelates
- Pregnant, breast feeding, or planning to become pregnant during the trial
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 |
|---|---|---|
| gadoteric acid | Drug | – |
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 26 Nov 2008.
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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.
Corinne Dubourdieu, PhD study chair
Guerbet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gadoteric acid in people with Arterial Occlusive Disease, run by Guerbet at 1 site in South Korea.
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 5 inclusion and 6 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 26 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
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 26 Nov 2008.