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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: Completed Phase 4 study, sponsored by Bayer.
NCT03602339 is a Phase 4 study that has completed, run by Bayer. The registered enrollment target is 157 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Degree of lesion contrast enhancement is assessed by 3 blinded Readers (Full Analysis Set). Results are presented as the Average Reader score. Blinded Readers scored up to 5 lesions using image sequences and a 4-point scale (1 - No = Lesion not enhanced; 2 - Moderate = Lesion weakly enhanced; 3 - Good = Lesion clearly enhanced; 4 - Excellent = Lesion clearly and brightly enhanced).
Interventions
- DRUG Gadoterate (Dotarem/Clariscan)
- DRUG Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2018-11-14 |
| Est. Completion | 2020-05-26 |
| Phase | Phase 4 |
What the finished NCT03602339 record still lists
NCT03602339 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Gadoterate (Dotarem/Clariscan) is the first listed.
NCT03602339 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03602339's enrollment target sits among peer trials
157 519th of 2000 higher than 1,480 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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