Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00709852 · 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
- 402
- Enrollment target
NCT00709852: Completed Phase 3 study, sponsored by Bayer.
NCT00709852 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 402 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00709852, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 402 participants
- Enrollment target
Study Summary
This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR images of the brain and spine. The results of the MRI with gadobutrol Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with ProHance.
Primary Outcome
BR1 evaluated the images from the unenhanced 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 = sufficiently visible.
Interventions
- DRUG Gadobutrol (Gadavist, Gadovist, BAY86-4875)
- DRUG Gadoteridol (ProHance)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2008-06 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00709852 record still lists
NCT00709852 is an interventional study that assigns participants to a tested intervention. The registered 402 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 (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Gadobutrol (Gadavist, Gadovist, BAY86-4875) is the first listed.
NCT00709852 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00709852 about?
NCT00709852 is a clinical study titled "Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging". This study involves the use of Magnetic Resonance Imaging (MRI) contrast agents called gadobutrol (Gadavist) Injection and ProHance Injection. The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of gadobutrol when used for taking MR ima...
What is the current status of trial NCT00709852?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 402 participants. The study started on 2008-06. Estimated completion is 2009-04.
What interventions are being tested in trial NCT00709852?
The interventions under investigation include: Gadobutrol (Gadavist, Gadovist, BAY86-4875) (DRUG), Gadoteridol (ProHance) (DRUG).
Who is sponsoring clinical trial NCT00709852?
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 NCT00709852's enrollment target sits among peer trials
402 919th of 2000 higher than 1,080 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04464226 · 402 participants · Phase 3
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer
- NCT05183763 · 402 participants · NA
Medication Adherence Program
- NCT06748222 · 402 participants · Phase 3
E-Mindfulness Approaches for Living After Breast Cancer
- NCT06896474 · 402 participants · NA
SDM POSSIBLE: A Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia