Ro47-0203 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症2

86. 肺動脈性肺高血圧症


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
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
2JPRN-JapicCTI-121998
01/9/200926/10/2012Bosentan PAH (WHO-FC II)Open label multicenter study to assess the efficacy, safety, and tolerability of bosentan in Japanese patients with pulmonary arterial hypertension (PAH) in WHO functional class II. Pulmonary arterial hypertension (PAH)Intervention name : Ro47-0203
INN of the intervention : Bosentan
Dosage And administration of the intervention : Oral administration, Initial dose: 62.5 mg b.i.d. for 4 weeks for all patients, Target dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)
Actelion Pharmaceuticals Japan Ltd.NULL1874BOTH16Phase 3NULL