Magnetic Resonance AngiographyPhase 2NCT00652418
Magnevist (SH L 451A) Intra-individual Dose Comparison Study in Magnetic Resonance Angiography
A Phase 2 study testing Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) in people with Magnetic Resonance Angiography and Peripheral Vascular Diseases, run by Bayer at 3 sites in Japan.
Trial summary
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases
- What is being tested?
- Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesJapan
- Study dates
- Jul 2004to Oct 2004
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
Who cannot join
- Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
- Patients with allergy to contrast media
- Patients with serious hepatic impairment
- Patients with serious renal impairment
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Funai-gun, Kyoto, 629-0197
Study site
Hamamatsu, Shizuoka, 431-3192
Study site
Hirosaki-shi, Aomori, 036-8563
About this study
Official title: Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.
- Conditions
- Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases
- Being tested
- Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)
- Keywords
- Magnevist, Magnetic Resonance Angiography, Meglumine gadopentetate, Determination of effective dose in MRA
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)Drug
Magnevist at a dose of 0.1 mmol/kg
Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)Drug
Magnevist at a dose of 0.2 mmol/kg
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) |
| Arm 2 | Experimental | Not described Receives: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic ability
Measured: MRI image in blinded read
Secondary outcomes (2)
Visibility
Measured: MRI image in blinded read
Diagnostic confidence
Measured: MRI image in blinded read
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2008 (estimated)
- Study startJul 2004
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance AngiographyStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652418
- Sponsor's protocol ID
- 91396
- Other IDs
- 308612
- Status last verified
- Oct 2013
- First submitted
- 1 Apr 2008
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities
- ClinicalTrials.gov ID
- NCT00652418
- Acronym / sponsor ID
- 91396
- Conditions
- Magnetic Resonance Angiography, Peripheral Vascular Diseases, Peripheral Arterial Diseases
- Keywords
- Magnevist, Magnetic Resonance Angiography, Meglumine gadopentetate, Determination of effective dose in MRA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 3 Apr 2008 (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.
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) |
| Arm 2 | Experimental | Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
Key exclusion criteria (4 listed)
- Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
- Patients with allergy to contrast media
- Patients with serious hepatic impairment
- Patients with serious renal impairment
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 |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)Magnevist at a dose of 0.1 mmol/kg | Drug | Arm 1 |
| Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A)Magnevist at a dose of 0.2 mmol/kg | Drug | Arm 2 |
Primary outcome
Diagnostic ability
Time frame: MRI image in blinded read
2 secondary outcomes
Visibility
Time frame: MRI image in blinded read
Diagnostic confidence
Time frame: MRI image in blinded read
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 14 Oct 2013.
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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.
Bayer Study Director study director
Bayer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) in people with Magnetic Resonance Angiography and Peripheral Vascular Diseases, run by Bayer at 3 sites in Japan.
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 4 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 14 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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 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.
What does the primary outcome measure?
Diagnostic ability (time frame: MRI image in blinded read). 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 14 Oct 2013.