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NCT03602339 · ClinicalTrials.gov registry record · Phase 4

Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose

A Phase 4 study, sponsored by Bayer.

Completed
Registry status
Phase 4
Development phase
157
Enrollment target

NCT03602339 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 157 participants.

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The verdict

NCT03602339, a Phase 4 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 4
Development phase
157 participants
Enrollment target

Study Summary

The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gadobutrol and gadoterate contain an element called gadolinium that is applied to improve the analysability of MRI-images. The purpose of this study was to examine if contrast-enhanced MRI using a reduced dose of the gadolinium-based contrast agent gadobutrol delivers images of similar quality to those obtained when a full dose of the gadolinium-based contrast agent gadoterate was used.

Interventions

  • DRUG Gadoterate (Dotarem/Clariscan)
  • DRUG Gadobutrol (Gadavist/Gadovist, BAY86-4875)

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2018-11-14
Est. Completion 2020-05-26
Phase Phase 4

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT03602339

The ClinicalTrials.gov registry entry for NCT03602339 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 157 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 2 interventions - of which Gadoterate (Dotarem/Clariscan) is the first listed.

NCT03602339 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03602339 about?

NCT03602339 is a clinical study titled "Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose". The study was conducted to gain knowledge about a new dose of a diagnostic drug that is used for contrast-enhanced Magnetic Resonance Imaging (MRI) of the human central nervous system (CNS). MRI can visualize the anatomy of the body and is used to detect medical conditions. Diagnostic drugs like gad...

What is the current status of trial NCT03602339?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 157 participants. The study started on 2018-11-14. Estimated completion is 2020-05-26.

What interventions are being tested in trial NCT03602339?

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

Who is sponsoring clinical trial NCT03602339?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.