Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gadopentetate dimeglumine · 6 trials · 6 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 | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Arm 5 | ACTIVE_COMPARATOR | - |
| Arm 6 | PLACEBO_COMPARATOR | - |
| 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 |
| Moxifloxacin (BAY12-8039) | DRUG | 400 mg at 0,07 mL/sec over 60 min |
| Placebo | DRUG | 0,9% saline at 0,6mL/kg at bolus rate |
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 in magnetic resonance imaging (MRI) to detect structural abnormalities in blood vessels, including peripheral vascular disease, renal artery stenosis, and cardiovascular abnormalities. It is also studied for use in MRI in children aged 2 months to under 2 years.
Gadopentetate dimeglumine is developed by Bayer AG, which trades under the ticker BAYRY. The company has conducted clinical trials for this contrast agent in various imaging applications.
Gadopentetate dimeglumine is in Phase 3 clinical development. It is an investigational contrast agent, not yet approved by the FDA. All four Phase 3 trials listed have been completed.
Gadopentetate dimeglumine has completed four Phase 3 trials: NCT00185276 for peripheral vascular disease, NCT00310557 for renal artery stenosis, NCT00310609 for cardiovascular abnormalities, and NCT00937391 for MRI in children. These trials are completed, with no active trials ongoing.
Gadopentetate dimeglumine is a small molecule contrast agent. It enhances magnetic resonance angiography (MRA) images by increasing the contrast between blood vessels and surrounding tissue, allowing better detection of structural abnormalities.
Yes, Gadopentetate dimeglumine is also known as Magnevist. Clinical trials reference Magnevist Injection, which is the brand name for this contrast agent used in enhanced MRA procedures.