Ro47-0203 / ACT-050088 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症1
86肺動脈性肺高血圧症1

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-132176
01/6/2013Bosentan DUA prospective, multicenter, single arm, open-label, phase III study to assess the safety and efficacy of bosentan in patients with digital ulcers associated with systemic sclerosis (SSc) Digital ulcers associated with systemic sclerosisIntervention name : Ro47-0203 / ACT-050088
INN of the intervention : Bosentan
Dosage And administration of the intervention : Total Daily dose should be 125 mg and bosentan tablet 62.5 mg should be given twice daily (b.i.d.) after meal in the morning and evening for the first four weeks. If tolerable, the daily dosage can be increased up to 250 mg (125 mg b.i.d) from Week 5.
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.NULL18BOTH20Phase 3NULL

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-132154
01/5/2013Bosentan for PAH pediatric patientsOpen-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of bosentan in Japanese children with pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)Intervention name : Ro47-0203 / ACT-050088
INN of the intervention : bosentan
Dosage And administration of the intervention : Oral administration, 2 mg/kg b.i.d, Patients are not to receive a dose exceeding 120 mg b.i.d.
Control intervention name : null
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH5Phase 3NULL