Gadovist (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 2 |
| 22 | もやもや病 | 1 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2009-014857-34-DE (EUCTR) | 01/02/2010 | 21/12/2009 | Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS | Intra-individual, randomized multicentric comparison of the MRI contrast agents Gadovist 1.0 versus Dotarem in patients with Multiple Sclerosis at 3T - Gadovist in MS | Patients with clinically definite MS or a clinically isolated episode of CNS involvement and disease dissemination in space, according to the McDonald’s criteria MedDRA version: 12.0;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: Gadovist 1.0 mmol/ml Injektionslösung Product Code: V08CA09 INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL Trade Name: Dotarem 0,5mmol/ml, Product Code: V08CA02 INN or Proposed INN: gadoteric acid | Universitätsklinikum Erlangen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Germany | |||
| 2 | EUCTR2009-016140-39-ES (EUCTR) | 19/01/2010 | 28/10/2009 | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | MRI in Clinically Isolated Syndromes and relapsing multiple sclerosis after single dose (0.1 mmol/kg) and cumulative dose (0.1 + 0.1 mmol/kg) of GADOVIST at 3.0T Estudio de resonancia magnética 3.0T posterior a la administración de GADOVIST® en dosis única (0.1 mmol/kg) y dosis acumulada (0.1+0.1 mmol/kg) en pacientes con Síndrome Clínico Aislado o recaída de Esclerosis Múltiple. | Realce de contraste en resonancia magnética enpacientes con Síndrome Clínico Aislado orecaída de Esclerosis Múltiple con resonanciamagnética anormal anterior después de laadministración de dosis única y acumulada deGADOVIST®High field strength MRI in patients with clinically isolated syndromes or relapsing MS with abnormal previous MRI after single and double dose of Gadovist® | Trade Name: GADOVIST 1 mmol/ml solución inyectable en jeringa precargada/ cartucho precargado INN or Proposed INN: GADOBUTROL Other descriptive name: GADOBUTROL | Institut Diagnostic per la Imatge | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCTs031180017 | 01/08/2018 | 07/09/2018 | Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease | Studies on the utility of simultaneous-multi-slice acquisition (SMS) dynamic susceptibility contrast-enhanced (DSC)MRI for the occulusive cerebrobascular disease - SMS DSC-MRI study for the occulusive cerebrobascular disease | carotid artery stenosis, moyamoya disease | Intravenous administration of gadobutrol (Gadovist, Bayer Schering Pharma, Berlin, Germany) is administered in the supine position, and high speed DSC-MRI scan by using SMS acquisition (temporal resolution of 0.5s) is carried out at the same time as injection of the contrast agent with an acquisition time of 70sec. The quantitative and qualitative comparison between reference data set (0.5s) and additional data sets with temporal resolution of 1.0s, 1.5s, and 2.0s generated from the reference data set, is performed. | Aoki Shigeki | Bayer Yakuhin, Ltd;Bayer Yakuhin, Ltd | Complete | >= 20age old | Not applicable | Both | 50 | N/A | Japan |