86. 肺動脈性肺高血圧症 [臨床試験数:1,083,薬物数:667(DrugBank:122),標的遺伝子数:98,標的パスウェイ数:185

Searched query = "Pulmonary arterial hypertension", "PAH", "IPAH", "HPAH", "Eisenmenger syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
13 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-JapicCTI-13215501/8/201311/06/2013Bosentan extension study for PAH pediatric patientsOpen-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. 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.
Actelion Pharmaceuticals Japan Ltd.NULL14BOTH5NULL
2EUCTR2004-000745-37-GB10/10/200623/02/2005Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensionUncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Spain;Italy;United Kingdom
3EUCTR2004-004391-36-CZ20/01/200605/01/2006A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
4EUCTR2005-001967-70-IT20/10/200519/01/2007An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1An open label long term safety and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 Treatment of pulmonary arterial hypertension in children
MedDRA version: 14.1Level: LLTClassification code 10037405Term: Pulmonary hypertension primarySystem Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
35Germany;United Kingdom;Italy
5EUCTR2004-004391-36-HU23/05/200523/02/2005A multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertensionA multicenter, open-label, single-arm safety study to investigate the effects of chronic TRACLEER® treatment on testicular function in male patients with pulmonary arterial hypertension Many endothelin receptor antagonists have profound effects on the histology and function of the testes in animals. These drugs have been shown to induce atrophy of the seminiferous tubules of the testes and to reduce sperm counts and male fertility in rats when administered for longer than 10 weeks. Where studied, testicular tubular atrophy and decreases in male fertility observed with endothelin receptor antagonists appear irreversible.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: no
Male: yes
23Hungary;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2004-000478-30-ES10/02/200503/11/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.There are no approved drug therapies for Class II PAH and the EARLY study is the first trial designed to enroll exclusively class II patients.Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
7EUCTR2004-000478-30-BE14/12/200424/08/2005Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Belgium;Denmark;Austria;Italy;United Kingdom;Sweden
8EUCTR2004-000478-30-AT08/12/200403/11/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
9EUCTR2004-000478-30-CZ26/11/200426/11/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
10EUCTR2004-000478-30-SE28/10/200420/07/2004Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2004-000745-37-ES11/10/200407/10/2004Uncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - ExtensionUncontrolled extension trial to protocol AC-052-406 to evaluate the long-term effects of bosentan therapy in patients with pulmonary arterial hypertension related to connective tissue disease (TRUST-Extension) - TRUST - Extension Pulmonary arterial hypertension (PAH) is characterized by increased pulmonary arterial pressure and pulmonary vascular resistance leading to right ventricular failure. PAH is a serious complication of many types of connective tissue disease (CTD). PAH is an important cause of morbidity in patients with connective tissue diseases . Once it is diagnosed, it is difficult to treat and has a very poor prognosisTrade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50United Kingdom;Spain;Italy
12EUCTR2004-000478-30-DK10/09/200410/01/2007Endothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYEndothelin antagonist trial in mildly symptomatic PAH patients. A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLY Patients with modified NYHA functional Class II PAH have mild symptoms, but their pulmonary artery pressures are elevated which leads to increased wall stress and silent heart damage progression. Therefore Class I-II patients have a better survival rate than Class III-IV patients (Odds ratio = 1.9) but will eventually deteriorate if untreated.
MedDRA version: 9.1Level: LLTClassification code 10064911Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Other descriptive name: ------------
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
170United Kingdom;Czech Republic;Denmark;Spain;Italy;Sweden
13EUCTR2005-001967-70-DE30/08/2005An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2 Idiopathic or familial pulmonary arterial hypertensionProduct Name: bosentan
Product Code: Ro 47-0203
INN or Proposed INN: bosentan monohydrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
30United Kingdom;Germany;Italy