Peripheral Vascular DiseasePhase 3NCT00408083
Crossover Study With MultiHance vs a Comparator for Peripheral MRA
A Phase 3 study testing MultiHance and Magnevist in people with Peripheral Vascular Disease, run by Bracco Diagnostics, Inc at 1 site in Italy.
Trial summary
This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- MultiHance and Magnevist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2006to Dec 2008
- 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
- Written informed consent
- At least 18 yrs of age
- Moderate to severe peripheral arterial disease
- Willing to undergo two MRA procedures within 14 days
Who cannot join
- Pregnant or lactating
- Known allergies to one or more ingredients in the products
- Therapeutic intervention in the arterial territory of interest between the two MRA exams
- Changes in symptoms between the two exams
- Vascular stent in area of interest
- Severe claustrophobia
Show all 9Show fewer
- Congestive heart failure class IV
- Scheduled to undergo surgery for PAOD between the two exams
- Scheduled to undergo DSA between the two exams
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries
This is a double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.
- Conditions
- Peripheral Vascular Disease
- Being tested
- MultiHance, Magnevist
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MultiHanceDrug
0.5 mmol/kg as a single dose administration
MagnevistDrug
0.5 mmol/kg as a single dose administration
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MultiHance MRI contrast agent Receives: Drug: MultiHance |
| 2 | Active comparator | Magnevist contrast agent for MRA Receives: Drug: Magnevist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of global paired diagnostic preference of the two MRA exams
Measured: Post dose
Secondary outcomes (1)
To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization
Measured: post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bracco Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gianpaolo Pirovano, MD, Study director, Bracco Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00408083
- Sponsor's protocol ID
- MH 127
- Status last verified
- Mar 2009
- First submitted
- 4 Dec 2006
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Double-Blind, Multi-Center, Randomized, Cross-Over Study to Compare 0.1 Mmol/kg of Multihance With 0.1 Mmol/kg of Magnevist for Contrast-Enhanced Magnetic Resonance Angiography(CE-MRA) of Peripheral Arteries
- ClinicalTrials.gov ID
- NCT00408083
- Acronym / sponsor ID
- MH 127
- Conditions
- Peripheral Vascular Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Dec 2006 (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 double blind crossover study designed to compare two different gadolinium products given at the same dose to patients undergoing MRA assessment of lower legs for the evaluation of peripheral steno-occlusive disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MultiHanceMultiHance MRI contrast agent |
| 2 | Active comparator | Drug: MagnevistMagnevist contrast agent for MRA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- At least 18 yrs of age
- Moderate to severe peripheral arterial disease
- Willing to undergo two MRA procedures within 14 days
Key exclusion criteria (9 listed)
- Pregnant or lactating
- Known allergies to one or more ingredients in the products
- Therapeutic intervention in the arterial territory of interest between the two MRA exams
- Changes in symptoms between the two exams
- Vascular stent in area of interest
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 |
|---|---|---|
| MultiHance0.5 mmol/kg as a single dose administration | Drug | 1 |
| Magnevist0.5 mmol/kg as a single dose administration | Drug | 2 |
Primary outcome
Assessment of global paired diagnostic preference of the two MRA exams
Time frame: Post dose
1 secondary outcome
To compare the two different products for signal intensity enhancement; average quality of visualization; technical failure rate; to assess inter-reader agreement in terms of average quality of visualization
Time frame: post dose
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 27 Mar 2009.
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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.
Gianpaolo Pirovano, MD study director
Bracco Diagnostics, Inc
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 MultiHance and Magnevist in people with Peripheral Vascular Disease, run by Bracco Diagnostics, Inc at 1 site in Italy.
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 9 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 27 Mar 2009. 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 Italy. 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?
Assessment of global paired diagnostic preference of the two MRA exams (time frame: Post dose). It is what the study was designed to measure, not a finding.
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 27 Mar 2009.