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Last Updated: December 15, 2024

CLINICAL TRIALS PROFILE FOR DOTAREM


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505(b)(2) Clinical Trials for Dotarem

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Dosage NCT03602339 ↗ Comparison of Gadovist 75% Standard Dose to Dotarem at Full Standard Dose Completed Bayer Phase 4 2018-11-14 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Dotarem

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00650845 ↗ Renal Safety Evaluation After DotaremĀ®-Enhanced MRI Completed Guerbet Phase 4 2008-01-01 Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (DotaremĀ®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.
NCT00764387 ↗ Contrast Enhanced MRI of the CNS - Patients With Known Cerebral Neoplastic Lesions. Completed Bayer Phase 4 2008-03-01 Study to compare of two contrast agents in imaging brain lesions.
NCT00845702 ↗ Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) Terminated Guerbet Phase 3 2009-04-01 The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
NCT00980681 ↗ Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF) Terminated Guerbet Phase 3 2009-09-01 The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dotarem

Condition Name

Condition Name for Dotarem
Intervention Trials
Magnetic Resonance Imaging 3
Breast Diseases 2
Cerebral Arterial Diseases 2
Multiple Sclerosis, Relapsing-Remitting 1
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Condition MeSH

Condition MeSH for Dotarem
Intervention Trials
Renal Insufficiency 4
Cardiomyopathies 2
Brain Neoplasms 2
Cerebral Arterial Diseases 2
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Clinical Trial Locations for Dotarem

Trials by Country

Trials by Country for Dotarem
Location Trials
United States 52
Korea, Republic of 11
Italy 9
Germany 7
France 5
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Trials by US State

Trials by US State for Dotarem
Location Trials
Massachusetts 6
Illinois 5
Indiana 4
North Carolina 3
Washington 3
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Clinical Trial Progress for Dotarem

Clinical Trial Phase

Clinical Trial Phase for Dotarem
Clinical Trial Phase Trials
Phase 4 16
Phase 3 6
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Dotarem
Clinical Trial Phase Trials
Completed 15
Recruiting 4
Terminated 4
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Clinical Trial Sponsors for Dotarem

Sponsor Name

Sponsor Name for Dotarem
Sponsor Trials
Guerbet 19
Massachusetts General Hospital 3
Bayer 2
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Sponsor Type

Sponsor Type for Dotarem
Sponsor Trials
Industry 23
Other 22
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