Bosentan administration
( DrugBank: Bosentan / KEGG DRUG: Bosentan, Bosentan )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 86 | Pulmonary arterial hypertension | 32 |
86. Pulmonary arterial hypertension
Clinical trials : 1,205 / Drugs : 684 - (DrugBank : 124) / Drug target genes : 100 - Drug target pathways : 193
Showing 1 to 10 of 32 trials
| 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-132155 | 01/8/201320130801 | 11/06/201320130611 | Bosentan extension study for PAH pediatric patients | Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of Japanese children with pulmonary arterial hypertension who completed the previous study. Open-label, long-term, efficacy, safety, and tolerability extension study using the pediatric formul ... | Pulmonary arterial hypertension (PAH) | Intervention name : Ro 47-0203 / 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. Intervention name : Ro 47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administrati ... | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | ||
| 2 | JPRN-JapicCTI-132154 | 01/5/201320130501 | 00000000 | 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 Open-label, multicenter study to assess the efficacy, safety, tolerability, and pharmacokinetics of ... | 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 Intervention name : Ro47-0203 / ACT-050088 INN of the intervention : bosentan Dosage And administratio ... | Actelion Pharmaceuticals Japan Ltd. | NULL | 14 | BOTH | 5 | Phase 3 | NULL | ||
| 3 | EUCTR2011-004106-16-BG (EUCTR) | 10/08/201220120810 | 11/06/201220120611 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in ... | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to a ... | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSEN ... | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia;Vietnam;India;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China United States;Serbia;Portugal;Philippines;Taiwan;Ukraine;Guatemala;Russian Federation;Chile;Colombia ... | ||
| 4 | EUCTR2011-004106-16-PT (EUCTR) | 01/06/201220120601 | 28/02/201220120228 | A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in the lung, to see how well bosentan decreases this high blood pressure and improves children's physical capabilities compared to an inactive compound A 5-month research project for children aged from 1 year to 17 years who have high blood pressure in ... | A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to assess efficacy, safety, and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 5 A randomized, prospective, double-blind, placebo-controlled, group sequential multicenter study to a ... | Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] Pulmonary arterial hypertension (PAH) in children MedDRA version: 14.1;Level: LLT;Classification cod ... | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSENTAN MONOHYDRATE Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: bosentan Other descriptive name: BOSEN ... | Actelion pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 105 | Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;South Africa;Bulgaria;Netherlands;China Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia ... | |||
| 5 | EUCTR2005-005068-97-BE (EUCTR) | 29/10/200920091029 | 10/06/200920090610 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Effects of combination of bosentanand sildenafil versus sildenafil monotherapy on morbidity and mort ... | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Effects of combination of bosentanand sildenafil versus sildenafil monotherapy on morbidity and mort ... | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indic ... | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTANMONOH ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden | ||
| 6 | JPRN-JapicCTI-121998 | 01/9/200920090901 | 26/10/201220121026 | 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. Open label multicenter study to assess the efficacy, safety, and tolerability of bosentanin Japanese ... | 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) Intervention name : Ro47-0203 INN of the intervention : Bosentan Dosage And administrationof the inter ... | Actelion Pharmaceuticals Japan Ltd. | NULL | 18 | 74 | BOTH | 16 | Phase 3 | NULL | |
| 7 | EUCTR2005-005068-97-CZ (EUCTR) | 16/06/200920090616 | 11/06/200920090611 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Effects of combination of bosentanand sildenafil versus sildenafil monotherapy on morbidity and mort ... | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Effects of combination of bosentanand sildenafil versus sildenafil monotherapy on morbidity and mort ... | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indic ... | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN MONOHYDRATE Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTANMONOH ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 8 | EUCTR2006-001464-23-GR (EUCTR) | 04/11/200820081104 | 30/01/200920090130 | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of or ... | A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg TID or placebo when added to Bosentan in the treatement of subjects , aged 18 years and above, with pulmonary arterial hypertension (PAH) - N/A A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of or ... | Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension Pulmonary Arterial Hypertension MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pu ... | Trade Name: Revatio Product Name: Revatio® Product Code: UK-92,480 INN or Proposed INN: Sildenafil | Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJ | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Greece;Germany;Italy;United Kingdom | |||
| 9 | EUCTR2005-005068-97-GR (EUCTR) | 23/09/200820080923 | 20/02/200920090220 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Effects of combination of bosentanand sildenafil versus sildenafil monotherapy on morbidity and mort ... | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 Effects of combination of bosentanand sildenafil versus sildenafil monotherapy on morbidity and mort ... | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indic ... | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203/029 Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other ... | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 10 | EUCTR2007-001643-21-GB (EUCTR) | 26/06/200820080626 | 10/10/200720071010 | Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lun ... | Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lung Disease. – A randomised, placebo-controlled, double-blinded study. - Tracleer in Interstitial Lung Disease and Pulmonary Hypertension Use of endothelin-1 antagonists in patients with Established Pulmonary Hypertension and Fibrotic Lun ... | Pulmonary hypertension in patients with interstitial lung disease. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension Pulmonary hypertension in patients with interstitial lung disease. MedDRA version: 9.1;Level: LLT;Cl ... | Trade Name: Tracleer Product Name: Tracleer INN or Proposed INN: Bosentan | Royal Brompton and Harefield NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 48 | Phase 4 | United Kingdom |