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"
12 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2005-005068-97-BE
(EUCTR)
29/10/200910/06/2009Effects 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 2Effects 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 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)
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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Spain;Belgium;Denmark;Germany;United Kingdom;Sweden
2EUCTR2005-005068-97-CZ
(EUCTR)
16/06/200911/06/2009Effects 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 2Effects 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 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)
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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
3EUCTR2005-005068-97-GR
(EUCTR)
23/09/200820/02/2009Effects 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 2Effects 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 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)
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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
4EUCTR2005-005068-97-PT
(EUCTR)
06/06/200811/03/2008Effects 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 2Effects 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 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:
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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
250Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
5EUCTR2005-005068-97-ES
(EUCTR)
11/05/200803/03/2008Effects 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 studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2Effects 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 studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 Hipertensión Arterial PulmonarPatients 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:
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Trade Name: Tracleer
Product Name: Bosentan
Product Code: Ro-47-0203
INN or Proposed INN: BOSENTAN
Other descriptive name: Ro-47-0203
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 4Portugal;Czech Republic;United Kingdom;Germany;Denmark;Spain;Greece;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2005-005068-97-SK
(EUCTR)
06/03/200806/07/2010A clinical trial to investigate the safety and effectiveness of the combination of bosentan and sildenafil to treat patients with symptomatic pulmonary arterial hypertension in comparison to treatment with sildenafil on its ownEffects 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 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: 14.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 14.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064908;Term: Associated with (APAH);System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;United Kingdom;Czech Republic;Belgium;Brazil;Denmark;Germany;Sweden
7EUCTR2005-005068-97-GB
(EUCTR)
30/10/200714/06/2007Effects 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 2Effects 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 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 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
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
250Phase 4Portugal;Czech Republic;Greece;Spain;Denmark;Germany;United Kingdom;Sweden
8EUCTR2005-005068-97-DK
(EUCTR)
12/09/200711/05/2007Effects 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 2Effects 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 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 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
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
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
9EUCTR2005-005068-97-SE
(EUCTR)
18/06/200702/04/2007Effects 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 2Effects 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 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 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
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
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden
10NCT00303459
(ClinicalTrials.gov)
May 200616/3/2006Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)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 StudyPulmonary Arterial HypertensionDrug: bosentan;Drug: placeboActelionNULLCompleted12 YearsN/AAll334Phase 4United States;Brazil;Czech Republic;Denmark;Germany;Greece;Portugal;Saudi Arabia;Slovakia;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT00303004
(ClinicalTrials.gov)
March 200614/3/2006Combination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeCombination Treatment With Bosentan and Sildenafil to Patients With Eisenmengers SyndromeEisenmenger SyndromeDrug: Bosentan and SildenafilRigshospitalet, DenmarkNULLCompleted18 YearsN/ABoth20Phase 3Denmark
12EUCTR2005-005068-97-DE
(EUCTR)
13/02/2006Effects 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 2Effects 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 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 10064909;Term: Idiopathic (IPAH)
MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro-47-0203
INN or Proposed INN: bosentan monohydrate
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil (as citrate)
Trade Name: Viagra
INN or Proposed INN: sildenafil
Trade Name: Revatio
INN or Proposed INN: sildenafil (as citrate)
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
350Phase 4Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden