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NCT01544166 · ClinicalTrials.gov registry record · Phase 1
Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT01544166 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 44 participants.
The verdict
NCT01544166, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol. A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days. Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial. The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.
Interventions
- DRUG Gadobutrol (Gadavist, BAY86-4875)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-05-16 |
| Est. Completion | 2013-11-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01544166
The ClinicalTrials.gov registry entry for NCT01544166 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gadobutrol (Gadavist, BAY86-4875) is the first listed.
NCT01544166 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01544166 about?
NCT01544166 is a clinical study titled "Gadobutrol Pharmacokinetic and Safety Study in Pediatric Subjects Aged <2 Years (Term Newborn Infants to Toddlers 23 Months of Age Inclusive)". The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol. A maximum total amount of approximately 5 ...
What is the current status of trial NCT01544166?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2012-05-16. Estimated completion is 2013-11-28.
What interventions are being tested in trial NCT01544166?
The interventions under investigation include: Gadobutrol (Gadavist, BAY86-4875) (DRUG).
Who is sponsoring clinical trial NCT01544166?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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