A Phase 3 interventional study of Gadobutrol (Gadavist, Gadovist, BAY86-4875) and Gadopentate dimeglumine (Magnevist, BAY86-4882) in Vascular Diseases, sponsored by Bayer. Completed at 3 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Bayer · Phase 3, Interventional, and Diagnostic
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.
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.
1,036 studies on the registry are indexed under Vascular Diseases; 166 are open to participants now.
This study's enrollment of 83 is close to the median of 80 across 643 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Bayer is the lead sponsor of 1,674 studies on the registry; 54 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 130 (61%) have results posted.
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Exclusion Criteria:
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
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
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) · Drug: Gadopentate dimeglumine (Magnevist, BAY86-4882)
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)
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)
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.
Time frame: 20-30 seconds after injection
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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20-30 seconds after injection
Participants were recruited at specialized study centers if they satisfied the inclusion and exclusion criteria. All had known or suspected stenosis of arterial vessels in different vascular body regions with an indication for contrast-enhanced magnetic resonance angiography for diagnosis and further treatment.
| Milestone | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol |
|---|---|---|
| Started | 41 | 42 |
| Completed | 41 | 42 |
| Not completed | 0 | 0 |
| Milestone | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol |
|---|---|---|
| Started | 41 | 42 |
| Completed | 39 | 37 |
| Not completed | 2 | 5 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Technical problems | 1 | 0 |
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.
| vessel segments | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| Investigators | 8.10 ± 3.685 | 8.33 ± 3.755 |
| Reader 1 | 8.03 ± 3.815 | 8.33 ± 3.852 |
| Reader 2 | 7.55 ± 4.622 | 7.88 ± 3.665 |
| Reader 3 | 5.27 ± 3.921 | 5.91 ± 3.666 |
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.
| Participants | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| improved | 63 | 65 |
| unchanged | 0 | 0 |
| worsened | 0 | 0 |
| missing or not applicable | 4 | 2 |
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.
| Participants | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| improved | 61 | 63 |
| unchanged | 0 | 0 |
| worsened | 1 | 0 |
| missing or not applicable | 4 | 3 |
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.
| Participants | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| improved | 56 | 63 |
| unchanged | 3 | 1 |
| worsened | 1 | 0 |
| missing or not applicable | 6 | 2 |
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.
| Participants | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| improved | 59 | 63 |
| unchanged | 0 | 0 |
| worsened | 2 | 0 |
| missing or not applicable | 5 | 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.
| Vessels | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| 100% diameter reduction (occlusion) | 6 | 8 |
| normal | 494 | 504 |
| <= 50% stenosis | 47 | 30 |
| > 50% stenosis | 32 | 32 |
| stenosis <= 70% | 5 | 3 |
| stenosis > 70% | 0 | 0 |
| not assessable | 271 | 278 |
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.
| Vessels | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| 100% diameter reduction (occlusion) | 5 | 5 |
| normal | 503 | 497 |
| stenosis <= 50% | 33 | 37 |
| stenosis > 50% | 22 | 24 |
| stenosis <= 70% | 2 | 1 |
| stenosis > 70% | 1 | 1 |
| not assessable | 272 | 273 |
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.
| Vessels | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| 100% diameter reduction (occlusion) | 15 | 10 |
| normal | 503 | 549 |
| <= 50% stenosis | 83 | 38 |
| > 50% stenosis | 21 | 16 |
| stenosis <= 70% | 1 | 1 |
| stenosis > 70% | 0 | 0 |
| not assessable | 215 | 224 |
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.
| Vessels | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| 100% diameter reduction (occlusion) | 3 | 2 |
| normal | 489 | 499 |
| <= 50% stenosis | 8 | 11 |
| > 50% stenosis | 15 | 17 |
| stenosis <= 70% | 2 | 1 |
| stenosis > 70% | 0 | 0 |
| not assessable | 321 | 308 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Gadobutrol (Gadavist, BAY86-4875) | — | 0/78 (0%) | 7/78 (9%) |
| Gadopentate Dimeglumine (Magnevist, BAY86-4882) | — | 0/81 (0%) | 7/81 (8.6%) |
| Event | Gadobutrol (Gadavist, BAY86-4875) | Gadopentate Dimeglumine (Magnevist, BAY86-4882) |
|---|---|---|
| NauseaGastrointestinal disorders | 1/78 | 0/81 |
| VertigoEar and labyrinth disorders | 1/78 | 0/81 |
| Blood pressure increasedInvestigations | 1/78 | 0/81 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/78 | 0/81 |
| PalpitationsCardiac disorders | 1/78 | 1/81 |
| C-reactive protein increasedInvestigations | 1/78 | 1/81 |
| RashSkin and subcutaneous tissue disorders | 1/78 | 0/81 |
| Rash papularSkin and subcutaneous tissue disorders | 0/78 | 1/81 |
| BronchitisInfections and infestations | 0/78 | 1/81 |
| Feeling hotGeneral disorders | 0/78 | 1/81 |
| Age, Continuous(Years) | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol | Total |
|---|---|---|---|
| Mean | 50.8 ± 14.26 | 55.3 ± 11.21 | 53.1 ± 12.93 |
| Sex: Female, Male(Participants) | Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine | Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 27 | 27 | 54 |
The record gives a start of Oct 2006, a primary completion of Oct 2007 and a completion of Oct 2007. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2011, 3 years 10 months after primary completion.
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This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gadobutrol