Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
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ClinicalTrials.gov Identifier: NCT00862459 |
Recruitment Status :
Completed
First Posted : March 17, 2009
Results First Posted : January 30, 2012
Last Update Posted : January 13, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic |
Conditions |
Brain Diseases Spinal Cord Diseases |
Interventions |
Drug: Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug: Gadobutrol~0.1 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug: Gadobutrol~0.3 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) Drug: OptiMARK~0.1 mmol/kg BW |
Enrollment | 237 |
Participant Flow
Recruitment Details | The date of the first participant's first visit was 27 August 2005. The date of the last participant's last visit was 26 March 2007. |
Pre-assignment Details | 242 participants were screened: 5 were screening failures (withdrew consent, did not meet study criteria, other). The remaining 237 were randomized to the 0.3, 0.1, or 0.03 millimole per kilogram (mmol/kg) group. |
Arm/Group Title | Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) |
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Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate. | Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. | Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. |
Period Title: Overall Study | |||
Started | 72 | 93 | 72 |
Participants Received Treatment | 70 [1] | 90 [2] | 69 [3] |
Completed | 66 | 85 | 66 |
Not Completed | 6 | 8 | 6 |
Reason Not Completed | |||
Lost to Follow-up | 1 | 2 | 2 |
Protocol Violation | 1 | 0 | 0 |
Withdrawal by Subject | 1 | 1 | 3 |
Adverse Event | 0 | 1 | 0 |
Personal reasons | 1 | 0 | 0 |
Operation | 1 | 1 | 0 |
Intravenous (IV) site problems | 1 | 0 | 1 |
Unable to hold still for imaging | 0 | 1 | 0 |
Inclusion/exclusion criteria not met | 0 | 1 | 0 |
Administrative problems | 0 | 1 | 0 |
[1]
Number reflects all treated participants of whom 67 received Gadobutrol and 70 received OptiMARK
[2]
Number reflects all treated participants of whom 90 received Gadobutrol and 88 received OptiMARK
[3]
Number reflects all treated participants of whom 68 received Gadobutrol and 69 received OptiMARK
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Baseline Characteristics
Arm/Group Title | Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875) | Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875) | Total | |
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Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate. | Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. | Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate. | Total of all reporting groups | |
Overall Number of Baseline Participants | 70 | 90 | 69 | 229 | |
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[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Years |
Number Analyzed | 70 participants | 90 participants | 69 participants | 229 participants |
<45 years | 36 | 42 | 29 | 107 | |
45-64 years | 24 | 39 | 28 | 91 | |
>=65 years | 10 | 9 | 12 | 31 | |
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 70 participants | 90 participants | 69 participants | 229 participants | |
Female |
33 47.1%
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58 64.4%
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38 55.1%
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129 56.3%
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Male |
37 52.9%
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32 35.6%
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31 44.9%
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100 43.7%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 70 participants | 90 participants | 69 participants | 229 participants |
Caucasian | 30 | 45 | 29 | 104 | |
Black | 7 | 8 | 3 | 18 | |
Hispanic | 3 | 6 | 3 | 12 | |
Asian | 1 | 1 | 0 | 2 | |
Other | 29 | 30 | 34 | 93 |
Outcome Measures
Adverse Events
Limitations and Caveats
OptiMARK was used as a standard of reference in this study. A formal comparison of the efficacy of gadobutrol and OptiMARK was not specified prospectively in the statistical analysis plan. For completeness, the safety data of OptiMARK is presented.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Publication of results will be a group publication. Sites with recruitment of >= 6 valid patients will contribute. There will be one author from each site having contributed >= 6 valid patients. Authorship listed according to recruitment. Sponsor will appoint up to 3 persons as co-authors. Main author of publication may be announced by site with most valid patients enrolled. In case more than 1 center reaches maximum patient No., main author will be from the center with fastest recruitment
Results Point of Contact
Name/Title: | Therapeutic Area Head |
Organization: | BAYER |
EMail: | clinical-trials-contact@bayerhealthcare.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00862459 |
Other Study ID Numbers: |
91400 308200 ( Other Identifier: company internal ) |
First Submitted: | November 26, 2008 |
First Posted: | March 17, 2009 |
Results First Submitted: | September 14, 2011 |
Results First Posted: | January 30, 2012 |
Last Update Posted: | January 13, 2014 |