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 |
| 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-JapicCTI-132154 | 01/5/2013 | Bosentan for PAH pediatric patients | Open-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. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | |||
| 2 | JPRN-JapicCTI-121998 | 01/9/2009 | 26/10/2012 | Bosentan 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. | NULL | 18 | 74 | BOTH | 16 | Phase 3 | NULL |