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NCT00623467 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging

A Phase 3 study, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
343
Enrollment target

NCT00623467: Completed Phase 3 study, sponsored by Bayer.

NCT00623467 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 343 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00623467, a Phase 3 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
343 participants
Enrollment target

Study Summary

This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. 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 will be compared to the results of images taken without Gadavist.

Primary Outcome

BR1 (reader 1 of 3) evaluated the images from the unenhanced magnetic resonance imaging (MRI) in one session and the images from the combined unenhanced and gadobutrol-enhanced MRIs in another. Contrast enhancement was scored on a 4-point scale where 1 = no enhancement and 4 = excellent enhancement. Border delineation was scored on a 4-point scale where 1 = no or unclear delineation and 4 = excellent delineation. Internal morphology was scored on a 3-point scale where 1 = poorly visible and 3 =

Interventions

  • DRUG Gadobutrol (Gadavist, Gadovist, BAY86-4875)

Trial Details

FieldValue
Enrollment Target 343 participants
Start Date 2007-12
Est. Completion 2008-12
Phase Phase 3
Bayer

591 total trials

What the finished NCT00623467 record still lists

NCT00623467 is an interventional study that assigns participants to a tested intervention. The registered 343 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 (56% lower).

The record links to 0 conditions, and to 1 intervention - of which Gadobutrol (Gadavist, Gadovist, BAY86-4875) is the first listed.

NCT00623467 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00623467 about?

NCT00623467 is a clinical study titled "Safety and Efficacy of Gadobutrol 1.0 Molar ( Gadavist ) in Patients for Central Nervous System (CNS) Imaging". This is a study involving the use of Magnetic Resonance Imaging (MRI) contrast agents called Gadavist. 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 th...

What is the current status of trial NCT00623467?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 343 participants. The study started on 2007-12. Estimated completion is 2008-12.

What interventions are being tested in trial NCT00623467?

The interventions under investigation include: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (DRUG).

Who is sponsoring clinical trial NCT00623467?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00623467's enrollment target sits among peer trials

343 1051st of 2000 higher than 948 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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Source: ClinicalTrials.gov NCT00623467, the US trial registry maintained by the National Library of Medicine. NCT00623467 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.