Carotid, Aortic, Renal or Peripheral Artery DiseasePhase 3VALUENCT01260636
Crossover Comparison of Two Gadolinium Contrast Agents for Use With MRA of Carotid, Renal and Peripheral Arteries
A Phase 3 study testing Gadobenate Dimeglumine and Gadopentetate Dimeglumine in people with Carotid, Aortic, Renal or Peripheral Artery Disease, run by Bracco Diagnostics, Inc at 1 site in China.
Trial summary
To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid, Aortic, Renal or Peripheral Artery Disease
- What is being tested?
- Gadobenate Dimeglumine and Gadopentetate Dimeglumine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2011
- Phase
- Phase 3
- 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
- 18 yrs of age or older
- referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
- Able to provide written informed consent and comply with protocol requirements
- Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol
Who cannot join
- pregnant or lactating females
- Known allergy to one or more of the ingredients in the products under investigation
- Significant congestive heart failure ( Class IV)
- Moderate to severe chronic kidney disease
- Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
- Vascular stents in vessels of interest
Show all 10Show fewer
- Received another contrast agent in the 24 hrs preceding or proceeding each exam
- Previously entered into the study
- Contraindications to MRI
- Severe Claustrophobia Undergone DSA between the two exams
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries
To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries
- Being tested
- Gadobenate Dimeglumine, Gadopentetate Dimeglumine
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobenate DimeglumineDrug
Also called MultiHance
0.1 mmol/kg, single dose
Gadopentetate DimeglumineDrug
Also called Magnevist
Double dose of 0.2 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| MultiHance contrast agent | Experimental | MultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg) Receives: Drug: Gadobenate Dimeglumine |
| Magnevist | Active comparator | Magnevist administered at a dose of 0.2 mmol/kg Receives: Drug: Gadopentetate Dimeglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Preference
Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference
Measured: Immediately post dose
Secondary outcomes (1)
Safety comparison of two diagnostic agents
to compare the safety of the two investigational products in patients undergoing CE-MRA of the carotid, renal/abdominal and peripheral arteries
Measured: UP to 24 hours post dose of each contrast agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
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 Carotid, Aortic, Renal or Peripheral Artery 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260636
- Sponsor's protocol ID
- MH-137
- Acronym
- VALUE
- Status last verified
- Jan 2012
- First submitted
- 13 Dec 2010
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Li Y, Li X, Li D, Lu J, Xing X, Yan F, Li Y, Wang X, Iezzi R, De Cobelli F. Multicenter, intraindividual comparison of single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine for MR angiography of the supra-aortic arteries (the Supra-Aortic VALUE study). AJNR Am J Neuroradiol. 2013 Apr;34(4):847-54. doi: 10.3174/ajnr.A3298. Epub 2012 Oct 4.
PubMed 23042922
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Comparative Multi-center Randomized Double-blind, Crossover Study of the Safety, Tolerability and Diagnostic Efficacy of Gadobenate Dimeglumine and Gadopentetate Dimeglumine in Magnetic Resonance Angiography of the Carotid, Renal/Abdominal and Peripheral Arteries
- ClinicalTrials.gov ID
- NCT01260636
- Acronym / sponsor ID
- VALUE / MH-137
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Dec 2010 (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.
To compare two gadolinium contrast agents in terms of global paired diagnostic preference (primary endpoint) for the assessment of contrast-enhanced MR Angiography of the carotid, renal/abdominal and peripheral arteries
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MultiHance contrast agent | Experimental | Drug: Gadobenate DimeglumineMultiHance administered at a dose of 0.1 mmol/kg (0.2 mL/kg) |
| Magnevist | Active comparator | Drug: Gadopentetate DimeglumineMagnevist administered at a dose of 0.2 mmol/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 yrs of age or older
- referred for enhanced MRA of carotid, renal/abdominal or peripheral arteries
- Able to provide written informed consent and comply with protocol requirements
- Highly suspected of or with known disease of the carotid, renal/abdominal or peripheral vasculature using specific criteria listed in the protocol
Key exclusion criteria (10 listed)
- pregnant or lactating females
- Known allergy to one or more of the ingredients in the products under investigation
- Significant congestive heart failure ( Class IV)
- Moderate to severe chronic kidney disease
- Therapeutic intervention of any kind for vascular disease in the territory of interest between the two contrast procedures
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 |
|---|---|---|
| Gadobenate DimeglumineAlso: MultiHance0.1 mmol/kg, single dose | Drug | MultiHance contrast agent |
| Gadopentetate DimeglumineAlso: MagnevistDouble dose of 0.2 mmol/kg | Drug | Magnevist |
Primary outcome
Diagnostic Preference
Time frame: Immediately post dose
Comparison of a single dose of MultiHance versus the double dose of Magnevist currently used for MR Angiography of the carotid, renal/abdominal/ and peripheral arteries in terms of global diagnostic perference
1 secondary outcome
Safety comparison of two diagnostic agents
Time frame: UP to 24 hours post dose of each contrast agent
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 5 Jan 2012.
- Derived from this study: PubMed 23042922Li Y, Li X, Li D, Lu J, Xing X, Yan F, Li Y, Wang X, Iezzi R, De Cobelli F. Multicenter, intraindividual comparison of single-dose gadobenate dimeglumine and double-dose gadopentetate dimeglumine for MR angiography of the supra-aortic arteries (the Supra-Aortic VALUE study). AJNR Am J Neuroradiol. 2013 Apr;34(4):847-54. doi: 10.3174/ajnr.A3298. Epub 2012 Oct 4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gadobenate Dimeglumine and Gadopentetate Dimeglumine in people with Carotid, Aortic, Renal or Peripheral Artery Disease, run by Bracco Diagnostics, Inc at 1 site in China.
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 4 inclusion and 10 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 5 Jan 2012. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Diagnostic Preference (time frame: Immediately post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01260636, 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 5 Jan 2012.