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Mallinckrodt
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Harvard Business School

Generated: February 20, 2019

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CLINICAL TRIALS PROFILE FOR DOTAREM

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Clinical Trials for Dotarem

Trial ID Title Status Sponsor Phase Summary
NCT00650845 Renal Safety Evaluation After Dotarem®-Enhanced MRI Completed Guerbet Phase 4 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 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 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 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 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 The study will evaluate the efficacy and safety of Dotarem enhanced MRA in patients suffering from carotid or vertebral arterial disease.
NCT01026389 Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease Completed Guerbet Phase 4 This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Dotarem

Condition Name

Condition Name for Dotarem
Intervention Trials
Magnetic Resonance Imaging 2
Cerebral Arterial Diseases 2
Renal Dysfunction 1
Coronary Atherosclerosis 1
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Condition MeSH

Condition MeSH for Dotarem
Intervention Trials
Renal Insufficiency 4
Renal Insufficiency, Chronic 2
Cerebral Arterial Diseases 2
Kidney Diseases 2
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Clinical Trial Locations for Dotarem

Trials by Country

Trials by Country for Dotarem
Location Trials
United States 45
Korea, Republic of 10
Italy 8
Germany 7
France 5
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Trials by US State

Trials by US State for Dotarem
Location Trials
Massachusetts 5
Indiana 4
Washington 3
New York 3
Illinois 3
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Clinical Trial Progress for Dotarem

Clinical Trial Phase

Clinical Trial Phase for Dotarem
Clinical Trial Phase Trials
Phase 4 14
Phase 3 5
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Dotarem
Clinical Trial Phase Trials
Completed 11
Not yet recruiting 5
Active, not recruiting 3
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Clinical Trial Sponsors for Dotarem

Sponsor Name

Sponsor Name for Dotarem
Sponsor Trials
Guerbet 13
Massachusetts General Hospital 2
Bayer 2
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Sponsor Type

Sponsor Type for Dotarem
Sponsor Trials
Industry 16
Other 12
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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Deloitte
Julphar
Cerilliant
Cantor Fitzgerald
US Department of Justice
Federal Trade Commission
QuintilesIMS
Queensland Health

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