Vascular DiseasesPhase 3NCT00395733
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
A Phase 3 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Gadopentate dimeglumine (Magnevist, BAY86-4882) in people with Vascular Diseases, run by Bayer at 3 sites in China.
Trial summary
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Gadopentate dimeglumine (Magnevist, BAY86-4882)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese origin
- Known or suspected blood vessel diseases
Who cannot join
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other trial
- Require emergency treatment
- Severely impaired liver and kidney functions
Trial locations and contacts
3 sites in 1 country.
China3 sites
Study site
Beijing, 100853
Study site
Chengdu, Sichuan, 610041
Study site
Shanghai, 200025
About this study
Official title: A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
Read the detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
- Conditions
- Vascular Diseases
- Being tested
- Gadobutrol (Gadavist, Gadovist, BAY86-4875), Gadopentate dimeglumine (Magnevist, BAY86-4882)
- Keywords
- Gadovist, Gadavist, MRI Imaging, vascular diseases, Chinese
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadobutrol (Gadavist, Gadovist, BAY86-4875)Drug
Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
Gadopentate dimeglumine (Magnevist, BAY86-4882)Drug
Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
| Study group | Role | What they receive |
|---|---|---|
| Gadobutrol, then Gadopentate dimeglumine | Experimental | Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882) |
| Gadopentate, dimeglumine then Gadobutrol | Experimental | Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged Receives: Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875); Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Vessel Segments Visualized With Diagnostic Quality
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.
Measured: 20-30 seconds after injection
Secondary outcomes (8)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
The on-site investigators assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Measured: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
Independent blinded reader 1 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Measured: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
Independent blinded reader 2 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Measured: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
Independent blinded reader 3 assessed the change in diagnostic confidence in the assessment of MRA scans before and after injection with Gadavist and Magnevist for each participant on a three-point scale as improved, unchanged or worsened.
Measured: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
MRA Diagnosis by Investigators
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Measured: 20-30 seconds after injection
MRA Diagnosis by Blinded Reader 1
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Measured: 20-30 seconds after injection
MRA Diagnosis by Blinded Reader 2
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Measured: 20-30 seconds after injection
MRA Diagnosis by Blinded Reader 3
The MRA diagnosis describes the pathology with regard to the extent of a stenosis, i.e., normal (no relevant disease), advanced arteriosclerosis but stenosis <= 50% (exemption: internal carotid artery: stenosis <= 70%), advanced arteriosclerosis, stenosis >50% but <99% (stenosis 50-99%) (exemption: internal carotid artery >70%), occlusion, and not assessable.
Measured: 20-30 seconds after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular DiseasesStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 83 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
- NCT00395733
- Sponsor's protocol ID
- 91537
- Other IDs
- 309762
- Status last verified
- Nov 2013
- First submitted
- 2 Nov 2006
- Last updated
- 18 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Intra-individual, Crossover, Multicenter Study of the Efficacy, Safety and Tolerability of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent in the Enhanced Magnetic Resonance Angiography (MRA) in Chinese Patients
- ClinicalTrials.gov ID
- NCT00395733
- Acronym / sponsor ID
- 91537
- Conditions
- Vascular Diseases
- Keywords
- Gadovist, Gadavist, MRI Imaging, vascular diseases, Chinese
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Nov 2006 (estimated)
- Results
- Posted 3 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.
Detailed description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gadobutrol, then Gadopentate dimeglumine | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875), Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged |
| Gadopentate, dimeglumine then Gadobutrol | Experimental | Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875), Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chinese origin
- Known or suspected blood vessel diseases
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Conditions interfering with MRI
- Allergy to any contrast agent or any drugs
- Participation in other 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 |
|---|---|---|
| Gadobutrol (Gadavist, Gadovist, BAY86-4875)Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) | Drug | Gadobutrol, then Gadopentate dimeglumine, Gadopentate, dimeglumine then Gadobutrol |
| Gadopentate dimeglumine (Magnevist, BAY86-4882)Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) | Drug | Gadobutrol, then Gadopentate dimeglumine, Gadopentate, dimeglumine then Gadobutrol |
Primary outcome
Number of Vessel Segments Visualized With Diagnostic Quality
Time frame: 20-30 seconds after injection
Each arterial segment visualized in magnetic resonance angiography (MRA) enhanced by Gadavist and Magnevist was characterized by the on-site investigators and by three independent blinded readers (reader 1, 2 and 3) according to a five-point scale (none/not assessable, poor, moderate, good, excellent), which takes into consideration intravascular contrast quality as well as vessel border delineation. The number of vessel segments with adequate diagnostic quality, i.e. good or excellent scores, was determined for each MRA image.
8 secondary outcomes
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Investigator
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 1
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 2
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
Change in Diagnostic Confidence From Pre- to Post-contrast MRA by Blinded Reader 3
Time frame: immediately before and 20-30 seconds after injection (precontrast and postcontrast)
MRA Diagnosis by Investigators
Time frame: 20-30 seconds after injection
MRA Diagnosis by Blinded Reader 1
Time frame: 20-30 seconds after injection
MRA Diagnosis by Blinded Reader 2
Time frame: 20-30 seconds after injection
MRA Diagnosis by Blinded Reader 3
Time frame: 20-30 seconds after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 3 study testing Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Gadopentate dimeglumine (Magnevist, BAY86-4882) in people with Vascular Diseases, run by Bayer at 3 sites 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 2 inclusion and 7 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 18 Dec 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 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?
Yes. Results are posted in the registry (first posted 3 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Vessel Segments Visualized With Diagnostic Quality (time frame: 20-30 seconds after injection). 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 18 Dec 2013.