Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging
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| ClinicalTrials.gov Identifier: NCT00709852 |
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Recruitment Status :
Completed
First Posted : July 3, 2008
Results First Posted : March 6, 2012
Last Update Posted : December 30, 2014
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic |
| Conditions |
Diagnostic Imaging Central Nervous System Diseases |
| Interventions |
Drug: Gadobutrol (Gadavist, Gadovist, BAY86-4875) Drug: Gadoteridol (ProHance) |
| Enrollment | 402 |
Participant Flow
| Recruitment Details | The date of the first participant's first visit was 11 JUN 2008. The date of the last participant's last visit was 03 APR 2009. |
| Pre-assignment Details | A total of 419 participants (part.) were screened; 17 prematurely discontinued prior to receiving any study drug. A total of 402 part. received study drug; 228 in gadobutrol : gadoteridol treatment sequence, 174 in gadoteridol : gadobutrol treatment sequence. Safety analysis set=402; gadobutrol=399, gadoteridol=393. Full analysis set (FAS)=336. |
| Arm/Group Title | Gadobutrol (Gadavist, BAY86-4875) : Gadoteridol (ProHance) | Gadoteridol (ProHance) : Gadobutrol (Gadavist, BAY86-4875) |
|---|---|---|
 Arm/Group Description |
Participants received a single dose of gadobutrol 0.1 mmol/kg body weight (bw) via i.v. (intravenous) in Period 1 and a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 2. | Participants received a single dose of gadoteridol at the approved dose, 0.1 mmol/kg bw, via i.v. in Period 1 and a single dose of gadobutrol 0.1 mmol/kg bw via i.v. in Period 2. |
| Period Title: Period 1 | ||
| Started | 228 | 174 |
| Completed | 220 | 171 |
| Not Completed | 8 | 3 |
| Reason Not Completed | ||
| Adverse Event | 2 | 0 |
| Withdrawal by Subject | 4 | 2 |
| Protocol Violation | 1 | 0 |
| Defective scanner | 0 | 1 |
| Lost to Follow-up | 1 | 0 |
| Period Title: Period 2 | ||
| Started | 220 | 171 |
| Completed | 211 | 169 |
| Not Completed | 9 | 2 |
| Reason Not Completed | ||
| Protocol Violation | 4 | 1 |
| Adverse Event | 1 | 1 |
| Lost to Follow-up | 1 | 0 |
| No 72-hour follow-up | 3 | 0 |
Baseline Characteristics
| Arm/Group Title | Entire Study Population | |
|---|---|---|
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Arm/Group Description |
Includes participants who received either treatment | |
| Overall Number of Baseline Participants | 402 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 402 participants |
| < 45 years | 144 | |
| 45-64 years | 164 | |
| ≥ 65 years | 94 | |
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 402 participants | |
| Female |
227 56.5%
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| Male |
175 43.5%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 402 participants |
| Caucasian | 235 | |
| Black | 23 | |
| Hispanic | 31 | |
| Asian | 112 | |
| Other | 1 | |