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


2 diseases
IDDisease name (Link within this page)Number of trials
51Scleroderma1
86Pulmonary arterial hypertension1

51. Scleroderma


Clinical trials : 525 Drugs : 565 - (DrugBank : 148) / Drug target genes : 114 - Drug target pathways : 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. Pulmonary arterial hypertension


Clinical trials : 1,205 Drugs : 684 - (DrugBank : 124) / Drug target genes : 100 - Drug target pathways : 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