BAY 1747846
Sponsors
Bayer AG
Conditions
Contrast enhancement in magnetic resonance imaging for assessment of central nervous system pathologyContrast enhancement in magnetic resonance imaging for assessment of non-central nervous system pathologyContrast enhancement in magnetic resonance imaging in children
Phase 3
(21197) A multicenter, randomized, prospective double-blind, cross over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of any body region (except CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
CompletedCTIS2022-501885-24-00
Start: 2023-09-20End: 2024-12-20Target: 265Updated: 2024-05-21
(21181) A multicenter, randomized, prospective double-blind, cross over Phase 3 study to evaluate the efficacy and safety of 0.04 mmol Gd/kg body weight of gadoquatrane for MRI in adults with known or suspected pathology of the central nervous system (CNS), compared to 0.1 mmol Gd/kg approved macrocyclic gadolinium-based contrast agents (GBCAs)
CompletedCTIS2022-501884-41-00
Start: 2023-09-29End: 2024-12-17Target: 186Updated: 2024-05-21
(21196) A multicenter, prospective, open-label study to evaluate the pharmacokinetics and safety of gadoquatrane in pediatric participants (from birth to <18 years) undergoing contrast-enhanced magnetic resonance imaging (CE-MRI)
CompletedCTIS2022-501883-17-00
Start: 2023-10-16End: 2024-11-21Target: 74Updated: 2024-09-25