Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gadopentetate dimeglumine (Magnevist)
Gadopentetate dimeglumine · 6 trials · 8 indications
A clinical judgment by the open-label Clinical Investigators (CIs) as to whether ("yes") or not ("no") the CI could make a diagnosis from the image.
Dose superiority was a calculation based upon the Blinder Readers' assessment of 4 visualization parameters
For each participant, the Blinded Reader indicated which dose had better contrast enhancement, better border delineation, clearer internal morphology, and provided more diagnostic information. The dose chosen for 3 or 4 of these variables was the selected dose for that Reader and participant. If each dose was superior on 2 variables, the dose which provided more diagnostic information was selected for that participant. The dose selected for the majority of participants was the dose selected by that Reader; if chosen by 2 or 3 Readers, it was the selected dose.
Total clearance is the fraction of the volume of distribution (Vd) which is completely purified per unit of time and depends also on the plasma half-life of the drug.
CL/BW = total clearance normalized by BW
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Vss/BW = volume of distribution at steady state normalized by body weight
AUC = Area under the drug concentration-time curve from administration to infinity
t 1/2 = termination elimination half-life calculated from the area under the drug concentration-time curve from administration to infinity
| Arm | Type | Description |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661) | EXPERIMENTAL | For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Gadopentetate dimeglumine (Magnevist, BAY86-6661) | DRUG | For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)). |
| Gadopentetate dimeglumine (Magnevist) | DRUG | Gadopentetate dimeglumine (Magnevist Injection), approximately 0.1mmol/kg body weight, single intravenous administration on the study day |
| Gadopentetate dimeglumine (Magnevist, BAY86-4882) | DRUG | Single intravenous injection on the study day: lower dose corresponding approx. 0.1 mmol/kg body weight |
| Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) | DRUG | Magnevist at a dose of 0.1 mmol/kg |
Inclusion Criteria: * Age: 2 months to \< 2 years (23 months) * Participants (male/female) who are scheduled to undergo gadolinium-enhanced MRI * Able to comply with the study procedures Exclusion Criteria: * Clinical unstable participants (eg, intensive care unit) * Renal Insufficiency * Partici...
Gadopentetate dimeglumine is a contrast agent used to enhance magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). Its studied uses include imaging of cardiovascular abnormalities, peripheral vascular disease, renal artery stenosis, and stenosis, as well as contrast-enhanced MRI in young children. It improves visualization of blood vessels and structural abnormalities during scans.
Gadopentetate dimeglumine is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer markets the agent under the brand name Magnevist. Development codes associated with the compound include BAY86-4882, BAY86-6661, and SH L 451A.
Gadopentetate dimeglumine has reached Phase 3 development. Its clinical program includes Phase 3 trials in contrast-enhanced MRI and magnetic resonance angiography, along with a completed Phase 2 dose comparison study. The Phase 3 studies have been completed, and no trials are currently listed as active.
Gadopentetate dimeglumine has been studied in completed trials including NCT00937391, a Phase 3 contrast-enhanced MRI study in children aged 2 months to under 2 years; NCT00310609, a Phase 3 MRA study of the aortic arch and cerebral branches; NCT00310557, a Phase 3 MRA study of renal artery stenosis; and NCT00652418, a Phase 2 dose comparison study.
Yes. Gadopentetate dimeglumine is the generic name for the agent marketed as Magnevist. Other development identifiers used for the same compound include BAY86-4882, BAY86-6661, and SH L 451A. Searches for any of these names refer to the same gadolinium-based contrast agent from Bayer.
Across the listed clinical trials, 365 participants have been enrolled in studies of gadopentetate dimeglumine. Individual trial enrollments range from 12 participants in a Phase 2 dose comparison study to 123 participants in a Phase 3 magnetic resonance angiography study. All listed trials are completed.