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NCT00862459 · ClinicalTrials.gov registry record · Phase 2
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 237
- Enrollment target
NCT00862459: Completed Phase 2 study, sponsored by Bayer.
NCT00862459 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 237 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00862459, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 237 participants
- Enrollment target
Study Summary
The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.
Primary Outcome
The primary visualization variables (number \[no.\] of lesions detected, border delineation, contrast enhancement, internal morphology) were condensed to a composite score (CVS). Each variable was considered a category; the CVS was calculated as: CVS=(No. of categories with increase over precontrast)-(No. of categories with decrease over precontrast). The possible outcomes of the CVS for a participant and each reader were in the range of - 3 to +4. The CVS was averaged across the 3 blinded reade
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2005-08 |
| Est. Completion | 2007-03 |
| Phase | Phase 2 |
What the finished NCT00862459 record still lists
NCT00862459 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (78% higher).
The record links to 0 conditions, and to 4 interventions - of which Gadobutrol~0.03 mmol/kg BW (Gadavist, Gadovist, BAY86-4875) is the first listed.
NCT00862459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00862459 about?
NCT00862459 is a clinical study titled "Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)". The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and w...
What is the current status of trial NCT00862459?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 237 participants. The study started on 2005-08. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00862459?
The interventions under investigation include: 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 (DRUG).
Who is sponsoring clinical trial NCT00862459?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00862459's enrollment target sits among peer trials
237 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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