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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR GADOTERATE MEGLUMINE

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All Clinical Trials for Gadoterate Meglumine

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.
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.
NCT01449266 ↗ Safety and Dialysability of Dotarem® in Dialysed Patients Completed Guerbet Phase 1 2011-11-01 To evaluate the dialysability of Dotarem®, after an IV injection of 0.1 mmol/kg in patients with chronic renal failure who require hemodialysis treatment.
NCT02411201 ↗ DOTAREM Pharmacokinetics and Safety Study in Pediatric Subjects Aged < 2 Years Completed Guerbet Phase 4 2015-03-01 The main purpose of the study is to evaluate the pharmacokinetics of DOTAREM® in the body of children aged less than 2 years thanks to several blood samples (3 ml in total) taken following the administration of DOTAREM®. DOTAREM® is a contrast agent commonly used for enhancement of Magnetic Resonance Imaging (MRI) to potentially improve the quality of the images and help the diagnosis. Children aged less than 2 years scheduled to undergo routine gadolinium-enhanced MRI of any body region may take part in the study. In this case they will receive DOTAREM®, a solution injected at the standard dose of 0.2mL/kg (0.1 mmol/kg) of body weight.
NCT03000036 ↗ Doxorubicin-associated Cardiac Remodeling Followed by CMR in Breast Cancer Patients Completed Fundação de Amparo à Pesquisa do Estado de São Paulo N/A 2012-07-01 Twenty-seven breast cancer women without heart failure, underwent CMR imaging (3T-Achieva, Philips) before and 3 times serially after 4-cycles of adjuvant DOX (60mg/m2). CMR assessed left ventricular (LV) ejection fraction (EF), T1 mapping pre and post gadolinium and late gadolinium enhancement imaging. Biomarkers were obtained before and 72 hours after each DOX-cycle.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Gadoterate Meglumine

Condition Name

Condition Name for Gadoterate Meglumine
Intervention Trials
Breast Diseases 2
Cerebral Arterial Diseases 2
Doxorubicin Induced Cardiomyopathy 1
Breast Cancer Female 1
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Condition MeSH

Condition MeSH for Gadoterate Meglumine
Intervention Trials
Breast Neoplasms 2
Cerebral Arterial Diseases 2
Renal Insufficiency 2
Breast Diseases 2
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Clinical Trial Locations for Gadoterate Meglumine

Trials by Country

Trials by Country for Gadoterate Meglumine
Location Trials
United States 3
France 2
Belgium 2
Italy 1
Austria 1
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Trials by US State

Trials by US State for Gadoterate Meglumine
Location Trials
Indiana 2
Massachusetts 1
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Clinical Trial Progress for Gadoterate Meglumine

Clinical Trial Phase

Clinical Trial Phase for Gadoterate Meglumine
Clinical Trial Phase Trials
Phase 4 4
Phase 3 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for Gadoterate Meglumine
Clinical Trial Phase Trials
Completed 6
Not yet recruiting 3
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Clinical Trial Sponsors for Gadoterate Meglumine

Sponsor Name

Sponsor Name for Gadoterate Meglumine
Sponsor Trials
Guerbet 7
Bayer AG (Sponsor) 1
University of Chicago 1
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Sponsor Type

Sponsor Type for Gadoterate Meglumine
Sponsor Trials
Other 8
Industry 7
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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Harvard Business School
Medtronic
AstraZeneca
Colorcon

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