Trials / Completed
CompletedNCT01660841
Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging
A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 223 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Purpose of the study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gadobutrol (Gadovist, BAY86-4875) | A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight. |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2013-08-01
- Completion
- 2013-08-01
- First posted
- 2012-08-09
- Last updated
- 2014-10-01
Locations
15 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01660841. Inclusion in this directory is not an endorsement.