CLINICAL TRIALS PROFILE FOR DOTAREM
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505(b)(2) Clinical Trials for DOTAREM
| 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 | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for DOTAREM
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00650845 ↗ | Renal Safety Evaluation After Dotarem®-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 (Dotarem®) 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. |
| NCT01010932 ↗ | Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) | Completed | Guerbet | Phase 3 | 2009-10-01 | The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. |
| NCT01012674 ↗ | Carotid and Vertebral Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF) | Completed | Guerbet | Phase 3 | 2009-10-01 | The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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