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NCT01344447 · ClinicalTrials.gov registry record · Phase 3
Gadobutrol Enhanced MRA of the Supra-aortic Vessels
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 479
- Enrollment target
NCT01344447: Completed Phase 3 study, sponsored by Bayer.
NCT01344447 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 479 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01344447, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 479 participants
- Enrollment target
Study Summary
Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will compare the diagnostic results of Gadobutrol enhanced MRA images with MRA images taken without contrast agent using images from a CTA as the standard of reference, which may have been performed up to 60 days prior to enrolment. If a CTA has not been performed in this prior time period, a CTA is required for the study. MRA and CTA images will be collected for an independent review (blinded read).
Primary Outcome
Each vascular segment was visualized using unenhanced MRA and gadobutrol-enhanced MRA, characterized by the on-site investigators, three independent blinded readers (BR) (BR 1, BR 2 and BR 3) and majority readers (the outcome determined by at least two of the blinded readers). A segment was assessable if it was visualized along its entire length and if any region of stenosis, was measured reliably. There were 21 segments of the supra-aortic arteries assessed per participant.
Interventions
- DRUG Gadobutrol (Gadovist, BAY86-4875)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 479 participants |
| Start Date | 2011-05-12 |
| Est. Completion | 2014-05-28 |
| Phase | Phase 3 |
What the finished NCT01344447 record still lists
NCT01344447 is an interventional study that assigns participants to a tested intervention. The registered 479 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Gadobutrol (Gadovist, BAY86-4875) is the first listed.
NCT01344447 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01344447 about?
NCT01344447 is a clinical study titled "Gadobutrol Enhanced MRA of the Supra-aortic Vessels". Subjects referred for a routine CTA (computed tomography angiography) or MRA (magnetic resonance angiography) will be invited to participate in the study and subjects will be involved in the study for between 2 and 12 days. Two to three visits to the study doctor will be required. This study will c...
What is the current status of trial NCT01344447?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 479 participants. The study started on 2011-05-12. Estimated completion is 2014-05-28.
What interventions are being tested in trial NCT01344447?
The interventions under investigation include: Gadobutrol (Gadovist, BAY86-4875) (DRUG).
Who is sponsoring clinical trial NCT01344447?
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 NCT01344447's enrollment target sits among peer trials
479 804th of 2000 higher than 1,196 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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