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"
106 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04039464
(ClinicalTrials.gov)
April 1, 20211/7/2019Mono vs. Dual Therapy for Pediatric Pulmonary Arterial HypertensionKids MoD PAH Trial: Mono- vs. Duo-Therapy for Pediatric Pulmonary Arterial HypertensionPediatric Pulmonary HypertensionDrug: Mono-Therapy with Sildenafil;Drug: Duo-Therapy with Sildenafil + BosentanJohns Hopkins UniversityNULLNot yet recruiting4 Months18 YearsAll100Phase 3United States
2NCT03053739
(ClinicalTrials.gov)
December 201629/12/2016To Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisRandomized Controlled Trial to Compare the Efficacy of Combination Therapy vs Monotherapy for Pulmonary Arterial Hypertension in Systemic SclerosisAssociated Pulmonary Arterial HypertensionDrug: Sildenafil 20mg and Bosentan 62.5mg;Drug: Sildenafil 20mg and PlaceboPostgraduate Institute of Medical Education and ResearchNULLRecruiting18 YearsN/AAll50Phase 4India
3NCT02885012
(ClinicalTrials.gov)
June 20163/5/2016Crossover Study From Macitentan or Bosentan Over to AmbrisentanA Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: AmbrisentanMedical University of South CarolinaOchsner Health SystemTerminated18 Years80 YearsAll3Phase 4United States
4ChiCTR-OON-17013521
2015-02-012017-11-24Transition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective studyTransition from ambrisentan to bosentan in pulmonary arterial hypertension: A single center prospective study pulmonary arterial hypertensionambrisentan group:oral ambrisentan;bosentan group:oral bosentan;Shanghai Pulmonary HospitalNULLCompletedMaleambrisentan group:12;bosentan group:8;China
5NCT01827059
(ClinicalTrials.gov)
October 20135/4/2013Bosentan In Exercise Induced Pulmonary Arterial Hypertension in CongenitaL Heart diseasEA Randomized Placebo Controlled Trial to Analyze Changes in Pulmonary Arterial Pressures at Peak Exercise in Congenital Heart Disease Patients With Exercise-induced Pulmonary Arterial Hypertension Before and After Treatment With Bosentan, Compared to PlaceboPulmonary Arterial Hypertension;Congenital Heart DiseaseDrug: Bosentan;Drug: PlaceboAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)NULLActive, not recruiting18 YearsN/AAll12Phase 2Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6JPRN-JapicCTI-132155
01/8/201311/06/2013Bosentan 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.NULL14BOTH5Phase 3NULL
7JPRN-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
8NCT03236818
(ClinicalTrials.gov)
May 201318/3/2013Goal Oriented Strategy to Preserve Ejection Fraction TrialRaising the Bars in the Treatment of Pulmonary Arterial Hypertension: Goal Oriented Strategy to Preserve Ejection Fraction TrialPulmonary Arterial HypertensionDrug: ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)VU University Medical CenterNULLActive, not recruiting18 Years80 YearsAll30Phase 4Netherlands
9EUCTR2010-021825-11-BG
(EUCTR)
02/01/201320/11/2012A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
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
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
10NCT01712997
(ClinicalTrials.gov)
September 201222/10/2012Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension PatientsPhase ? Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension PatientsPulmonary Arterial HypertensionDrug: Iloprost;Drug: BosentanFourth Military Medical UniversityNULLRecruiting10 Years80 YearsBoth90Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2011-004106-16-BG
(EUCTR)
10/08/201211/06/2012A 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 compoundA 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 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105United 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
12EUCTR2011-004612-31-PT
(EUCTR)
06/07/201202/05/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105Portugal;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
13EUCTR2011-004106-16-PT
(EUCTR)
01/06/201228/02/2012A 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 compoundA 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 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
105Portugal;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
14EUCTR2010-021793-12-NL
(EUCTR)
09/11/201114/02/2011A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extensionA prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Germany;Netherlands;Italy
15NCT01548950
(ClinicalTrials.gov)
September 20115/3/2012Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary HypertensionCombined Clinical and Surgical Approaches to Congenital Heart Disease Associated With Pulmonary Arterial Hypertension (PAH-CHD)Congenital Heart Disease;Pulmonary Arterial HypertensionDrug: Sildenafil singly or in association with BosentanUniversity of Sao Paulo General HospitalInstituto do Coracao;Fundação de Amparo à Pesquisa do Estado de São PauloCompleted2 MonthsN/AAll50N/ABrazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01330108
(ClinicalTrials.gov)
May 20114/4/2011Safely Change From Bosentan to Ambrisentan in Pulmonary HypertensionSafely Change From Bosentan to Ambrisentan in Pulmonary HypertensionPulmonary Arterial HypertensionDrug: ambrisentanUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll32Phase 4United States
17EUCTR2010-021793-12-ES
(EUCTR)
28/04/201103/03/2011Estudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonarEstudio de extensión, prospectivo, multicéntrico y abierto del estudio FUTURE 3 para evaluar la seguridad, tolerabilidad y eficacia utilizando la formulación pediátrica de bosentan dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar Hipertensión arterial pulmonar (PAH) en niños.
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
18EUCTR2010-021825-11-NL
(EUCTR)
28/04/201103/11/2010A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Germany;Netherlands;China
19NCT01392469
(ClinicalTrials.gov)
April 20, 201110/5/2011Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension PatientsA Non-randomized, Multiple Dose, Three Treatment Period, Open-label, Single Sequence, Single Group Study to Evaluate the Pharmacokinetic Effect of Two Doses of QTI571 (Imatinib) on the Co-administered Drugs Sildenafil and Bosentan in Pulmonary Arterial Hypertension (PAH) PatientsPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
20EUCTR2010-021793-12-IT
(EUCTR)
10/04/201116/05/2011A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study ExtensionA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Study Extension Pulmonary Arterial Hypertension
MedDRA version: 13.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 13.1;Classification code 10064909;Term: Idiopathic (IPAH);Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Netherlands;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-021793-12-DE
(EUCTR)
04/04/201101/02/2011A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 16.1;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
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;South Africa;Germany;Netherlands;China
22JPRN-UMIN000005464
2011/04/0119/04/2011Drug interactions and effects of combination therapy for pulmonary arterial hypertension pulmonary arterial hypertensionphase 1: sildenafil (60mg/day) and bosentan (250mg/day) for 4 or 5 weeks
phase 2: sildenafil(60mg/day) and
ambrisentan (5mg/day) for 4 or 5 weeks
phase 3: tadalafil (40mg/day) and ambrisentan (5mg/day) for 4 or 5 weeks
Hamamatsu University School of MedicineUniversity of ShizuokaRecruiting20years-oldNot applicableMale and Female15Not applicableJapan
23EUCTR2010-021793-12-CZ
(EUCTR)
09/03/201104/02/2011A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
24NCT01223352
(ClinicalTrials.gov)
March 8, 201112/10/2010Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial HypertensionAn Open-label, Prospective Multicenter Study to Assess the Pharmacokinetics, Tolerability, Safety and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: bosentanActelionNULLCompleted3 Months12 YearsAll64Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic
25NCT01338415
(ClinicalTrials.gov)
March 8, 201115/4/2011FUTURE 3 Study ExtensionA Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted3 Months12 YearsAll58Phase 3United States;Australia;Belarus;China;Czechia;France;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Russian Federation;Serbia;South Africa;Spain;Ukraine;Czech Republic;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2010-021793-12-HU
(EUCTR)
28/02/201102/02/2011A 1 year follow-up research project for children with pulmonary arterialhypertension (PAH) that participated in the FUTURE 3 core study. This isto find out how well bosentan is tolerated and safe when taken eithertwo or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 16.1;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 100000004855
MedDRA version: 16.1;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
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64South Africa;Netherlands;Germany;China;United States;Belarus;Serbia;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia
27ChiCTR-ONC-11001799
2011-02-172011-12-15A single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseA single center, open lable clinical study of bosentan therapy in pediatric patients with severe pulmonary arterial hypertension due to congenital heart disease pediatric patients with severe pulmonary arterial hypertension due to congenital heart diseaseAll groups:Bosentan therapy ;Beijing Anzhen HospitalNULLCompleted018BothAll groups:50;China
28EUCTR2010-021344-17-IT
(EUCTR)
28/01/201107/02/2011A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - NDA non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: REVATIO
INN or Proposed INN: Sildenafil
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
24Italy
29EUCTR2010-021825-11-IT
(EUCTR)
17/01/201108/02/2011An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE-3 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064908
MedDRA version: 9.1;Classification code 10064909
MedDRA version: 9.1;Classification code 10064910
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
30JPRN-UMIN000004369
2011/01/0101/01/2011Application of Exercise Echocardiography and Treatment by Bosentan in Latent Pulmonary Arterial Hypertension Associated with Connective Tissue Disease Connective Tissue DiseaseBosentanTokushima UniversityNULLComplete: follow-up complete18years-old85years-oldMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2010-021825-11-ES
(EUCTR)
22/12/201012/11/2010Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3Estudio multicéntrico, prospectivo, abierto para evaluar la farmacocinética, tolerabilidad, seguridad y eficacia de la formulación pediátrica de bosentan, dos veces frente a tres veces al día en niños con hipertensión arterial pulmonar - FUTURE 3 Hpertensión arterial pulmonar (PAH) en niños
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: TRACLEER 62,5 mg comprimidos recubiertos con película
INN or Proposed INN: BOSENTAN MONOHIDRATO
Other descriptive name: BOSENTAN MONOHIDRATO
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
32EUCTR2010-021825-11-HU
(EUCTR)
08/12/201004/11/2010An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
33EUCTR2010-021825-11-CZ
(EUCTR)
03/12/201003/12/2010A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
34EUCTR2010-021825-11-DE
(EUCTR)
26/11/201008/11/2010A 7-month research project for children aged from 3 months to 11 years with pulmonary arterial hypertension to find out whether bosentan is best tolerated, and most safe and effective when taken two or three times a dayAn open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Hungary;Czech Republic;Mexico;Poland;Australia;Bulgaria;South Africa;Netherlands;Germany;China
35EUCTR2008-004533-21-NL
(EUCTR)
25/06/201014/11/2008The role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patientsThe role of Bosentan in fontan patients: improvement of aerobic capacity - bosentan in fontan patients To study whether bosentan (endothelin receptor inhibitor) improves aerobic capacity (VO2max) and exercise performance in adult patients with a Fontan operation.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Tracleer
Product Name: Tracleer
Product Code: 66215-101
INN or Proposed INN: BOSENTAN
Other descriptive name: Tracleer
ICINNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2005-005068-97-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
37JPRN-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
38EUCTR2005-005068-97-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
39NCT00864201
(ClinicalTrials.gov)
April 200917/3/2009A Study to Evaluate the Use of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue DiseaseA Pilot Study to Evaluate the Effect of Bosentan in Patients With Exercise Induced Pulmonary Arterial Hypertension Associated With Connective Tissue DiseaseHypertension, Pulmonary;Connective Tissue DiseaseDrug: bosentanHamilton Health Sciences CorporationActelionNot yet recruiting18 YearsN/ABoth10Phase 3Canada
40NCT01100736
(ClinicalTrials.gov)
January 200930/3/2010Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3)Characterisation of the Role of ETA and ETB Receptors in Regulating Plasma ET-1 and the Vasodilator Response to ET-3 in ManPulmonary Arterial Hypertension;Vasodilation;VasoconstrictionDrug: Bosentan;Drug: Sitaxsentan;Drug: Placebo;Biological: Endothelin-3University of EdinburghEncysive PharmaceuticalsCompleted18 Years70 YearsBoth10Phase 0United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00780728
(ClinicalTrials.gov)
December 200827/10/2008Study Evaluating the Addition of Sildenafil to Bosentan Therapy in Pulmonary Arterial HypertensionAddition of Sildenafil to Bosentan Monotherapy in Patients With Pulmonary Arterial Hypertension (PAH)Hypertension, PulmonaryDrug: SildenafilUniversity Health Network, TorontoNULLWithdrawn18 YearsN/ABothPhase 3Canada
42EUCTR2006-001464-23-GR
(EUCTR)
04/11/200830/01/2009A 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/AA 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 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
43EUCTR2005-005068-97-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
44NCT00825266
(ClinicalTrials.gov)
September 200816/1/2009Insulin Resistance in Pulmonary Arterial HypertensionThe Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentan;Drug: PioglitazoneStanford UniversityNULLTerminated18 Years75 YearsAll2Phase 2United States
45EUCTR2005-005068-97-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2005-005068-97-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
47NCT00581607
(ClinicalTrials.gov)
April 200826/12/2007Double Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary HypertensionDouble Blind, Randomized Trial of Bosentan for Sarcoidosis Associated Pulmonary HypertensionSarcoidosis;Pulmonary Arterial HypertensionDrug: Bosentan;Drug: PlaceboUniversity of CincinnatiActelionCompleted18 YearsN/ABoth43Phase 2/Phase 3United States
48EUCTR2005-005068-97-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
49NCT00909337
(ClinicalTrials.gov)
January 200827/5/2009Early Therapy of Pulmonary Arterial HypertensionEarly Therapy of Pulmonary Arterial HypertensionPulmonary Hypertension;Systemic SclerosisDrug: BosentanMedical University of GrazActelionCompleted18 Years90 YearsBoth10N/AAustria
50EUCTR2005-005068-97-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT00625469
(ClinicalTrials.gov)
October 200719/2/2008Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With BosentanTreatment of Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Hypertension With Bosentan: A Single Center Pilot StudyPulmonary Arterial Hypertension;Idiopathic Pulmonary FibrosisDrug: bosentanRajan SaggarActelionWithdrawnN/AN/AAll0Phase 4United States
52EUCTR2005-005068-97-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
53EUCTR2005-005068-97-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
54NCT00433329
(ClinicalTrials.gov)
March 20077/2/2007Combination Therapy in Pulmonary Arterial HypertensionCOMPASS 3: An Open-label, Multi-Center Study Employing a Targeted 6-Minute Walk Test (6-MWT) Distance Threshold Approach to Guide Bosentan-Based Therapy and to Assess the Utility of Magnetic Resonance Imaging (MRI) on Cardiac RemodelingPulmonary Arterial HypertensionDrug: Bosentan;Drug: SildenafilActelionNULLCompleted12 YearsN/AAll100Phase 4United States
55EUCTR2006-001464-23-IT
(EUCTR)
03/11/200619/02/2007A 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 TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - NDA 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 TREATMENT OF SUBJECTS, AGED 18 YEARS AND ABOVE, WITH PULMONARY ARTERIAL HYPERTENSION PAH - ND Pulmonary Arterial Hypertension PAH .
MedDRA version: 6.1;Level: PT;Classification code 10037400
Trade Name: G04BE03- Sildenafil - sildenafil (citrato)
Product Name: Sildenafil
INN or Proposed INN: Sildenafil
PFIZERNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2006-001464-23-GB
(EUCTR)
18/10/200611/06/2006A 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/AA 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 Pulmonary Arterial Hypertension
MedDRA version: 8.0;Level: LLT;Classification code 10064911
Pfizer LtdNULLNot Recruiting Female: yes
Male: yes
106 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4): yesCzech Republic;Greece;Germany;Italy;United Kingdom
57EUCTR2004-000745-37-GB
(EUCTR)
10/10/200623/02/2005Uncontrolled 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
58NCT00323297
(ClinicalTrials.gov)
September 20065/5/2006Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial HypertensionA 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 Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)Pulmonary Arterial HypertensionDrug: Bosentan;Other: Placebo;Drug: Sildenafil CitratePfizerNULLCompleted18 YearsN/AAll105Phase 4United States;Australia;Czech Republic;France;Germany;Greece;Israel;Italy;Taiwan;United Kingdom;Belgium
59EUCTR2006-001464-23-DE
(EUCTR)
04/07/200605/05/2006A multinational, multicentre, randomized, double-blind study to assess the efficacy and safety of oral sildenafil 20mg three times daily or placebo when added to bosentan in the treatment of adult subjects, withpulmonary arterial hypertension.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 Pulmonary Arterial Hypertension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Other descriptive name: n/a
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UKNULLNot RecruitingFemale: yes
Male: yes
106France;Czech Republic;Taiwan;Greece;Belgium;Australia;Israel;Germany;Italy;United Kingdom
60EUCTR2005-005066-37-DE
(EUCTR)
09/06/200606/11/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2United Kingdom;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2006-001464-23-CZ
(EUCTR)
08/06/200621/04/2006A 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/AA 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 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Revatio
Product Name: Revatio®
Product Code: UK-92,480
INN or Proposed INN: Sildenafil
Pfizer Ltd,Ramsgate Road,Sandwich CT13 9NJNULLNot RecruitingFemale: yes
Male: yes
106Czech Republic;Greece;Germany;Italy;United Kingdom
62NCT00303459
(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
63NCT00595049
(ClinicalTrials.gov)
May 20067/1/2008Pulmonary Artery Remodelling With BosentanOpen Label, Non Comparative Study to Investigate the Effect of Bosentan on Pulmonary Artery Remodelling in Pulmonary Arterial Hypertension (PAH).Hypertension, PulmonaryDrug: bosentanActelionNULLCompleted18 YearsN/ABoth11Phase 4Australia;United States
64EUCTR2005-005066-37-BE
(EUCTR)
21/04/200615/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxinsPatients are already on prescribed bosentan therapy for at least 12 weeks.Trade Name: viagra
Product Name: sildenafil
Product Code: N/A
INN or Proposed INN: Sildenafil citrate
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
44Phase 2Belgium;Germany;Italy;United Kingdom
65NCT01721564
(ClinicalTrials.gov)
April 20061/11/2012Bosentan and Pulmonary Endothelial FunctionPulmonary Artery Remodelling With BosentanPulmonary Arterial HypertensionDrug: BosentanProf David S CelermajerNULLCompleted18 Years80 YearsAll8N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2005-005066-37-IT
(EUCTR)
21/03/200605/06/2006Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS 1 Patients suffering from pulmonary arterial hypertension PAH
MedDRA version: 6.1;Level: PT;Classification code 10037400
INN or Proposed INN: SildenafilActelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
44Phase 2Germany;United Kingdom;Italy
67EUCTR2005-005066-37-GB
(EUCTR)
15/03/200613/02/2006COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1COMPASS-1 / Hemodynamic effects of a single dose of sildenafil in symptomatic patients on bosentan treatment for pulmonary arterial hypertension – A multicenter, open-label, non-comparative, prospective, phase II study - COMPASS-1 Symptomatic Pulmonary Arterial Hypertension (WHO functional class II-III) of the following types: - Idiopathic - Familial - Associated with: Corrected congenital systemic-to-pulmonary shunts Drugs and toxins Patients are already on prescribed bosentan therapy for at least 12 weeks.Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noBelgium;Germany;Italy;United Kingdom
68EUCTR2006-000021-57-DK
(EUCTR)
10/03/200624/02/2006Bosentan and Sildenfil for patients with Eisenmenger syndromeBosentan and Sildenfil for patients with Eisenmenger syndrome Eisenmengers syndrome is condition with severe pulmonary arterial hypertension due to a shunting of blood from the left side of the heart to the right side of the heart. When the pressure in the pulmonary arteries levels the systemic blood pressure, blood begins to shunt from the right side of the heart to the left side of the heart leading to a condition with cyanosis, impaired physical capacity and increased mortality (Eisenmengers syndrome).Trade Name: Tracleer
Product Name: Tracleer
Other descriptive name: Bosentan monohydrat
Trade Name: VIAGRA
Product Name: Viagra
Other descriptive name: sildenafil
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
20Denmark
69NCT00303004
(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
70NCT00310830
(ClinicalTrials.gov)
March 20063/4/2006Efficacy and Safety of Bosentan in Sickle Cell Disease (SCD) Patients With Pulmonary Arterial Hypertension (PAH)Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Symptomatic Pulmonary Arterial Hypertension Associated With Sickle Cell DiseasePulmonary HypertensionDrug: BosentanActelionNULLTerminated12 YearsN/ABoth14Phase 3United States;France;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT00302211
(ClinicalTrials.gov)
February 1, 200610/3/2006The VISION Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial HypertensionA Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral SildenafilPulmonary HypertensionDrug: Inhaled Iloprost (5 µg);Drug: Inhaled Placebo;Drug: Sildenafil;Drug: BosentanActelionNULLTerminated12 Years85 YearsAll67Phase 3United States
72EUCTR2004-004391-36-CZ
(EUCTR)
20/01/200605/01/2006A 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
73EUCTR2005-001967-70-IT
(EUCTR)
20/10/200519/01/2007An 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: 14.1;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System 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
74EUCTR2005-001967-70-GB
(EUCTR)
13/10/200525/08/2005An 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 hypertensionActelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany;Italy;United Kingdom
75NCT00319020
(ClinicalTrials.gov)
August 23, 200526/4/2006Bosentan in Children With Pulmonary Arterial Hypertension Extension StudyAn 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 1Pulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted2 Years11 YearsAll33Phase 3United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00593905
(ClinicalTrials.gov)
July 20053/1/2008Pharmacogenomics in Pulmonary Arterial HypertensionPharmacogenomics in Pulmonary Arterial Hypertension: A Multi-Center International Study to Determine Whether in PAH Patients Clinical Associations Exist Between the Efficacy and Toxicity of Endothelin Receptor Antagonists and Several Gene Polymorphisms in Several Key Disease-Specific and Therapy Specific GenesPulmonary Arterial Hypertension;Pulmonary Hypertension;PAH WHO Group IDrug: Sitaxsentan;Drug: Bosentan, AmbrisentanWest Penn Allegheny Health SystemNational Institutes of Health (NIH);Baylor College of Medicine;Emory University;University of Chicago;Johns Hopkins University;Tufts Medical Center;Sir Mortimer B. Davis - Jewish General Hospital;London Health Sciences Centre;University of Maryland;University of California, San Francisco;University of Calgary;Chest Medical Associates;Columbia University;Lung Diagnostics, Ltd.;Duke University;University of California, Los Angeles;Latter Day Saints Hospital;Louisiana State University Health Sciences Center in New Orleans;Massachusetts General Hospital;Mayo Clinic;Medical College of Wisconsin;Southeastern Lung Care;Suncoast Lung Center;Children's Hospital Colorado;University Hospital Case Medical Center;University of Colorado, Denver;University of Michigan;University of Pittsburgh;University of Southern California;The University of Texas, Galveston;Vanderbilt University;Wayne State University;Ohio State University;University of Alabama at Birmingham;Washington University School of Medicine;Sentara Norfolk General Hospital;University of Texas Southwestern Medical Center;Bay Area Chest PhysiciansRecruitingN/AN/ABoth1300N/AUnited States
77EUCTR2004-005157-63-GB
(EUCTR)
15/06/200519/04/2005An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1 Idiopathic or familial PAHActelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
33 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noItaly;United Kingdom
78EUCTR2004-005157-63-IT
(EUCTR)
15/06/200515/02/2006An open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAHAn open label multicenter study to assess the pharmacokinetic, tolerability and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension iPAH Treatment of pulmonary arterial hypertension in children.
MedDRA version: 6.1;Level: PT;Classification code 10037405
Trade Name: TRACLEER 62,5MG 56CPR RIV.
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
35United Kingdom;Italy
79EUCTR2004-004391-36-HU
(EUCTR)
23/05/200523/02/2005A 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
80NCT00319267
(ClinicalTrials.gov)
May 200526/4/2006Bosentan in Children With Pulmonary Arterial HypertensionAn Open Label, Multicenter Study to Assess the Pharmacokinetics, Tolerability, and Safety of a Pediatric Formulation of Bosentan in Children With Idiopathic or Familial Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: BosentanActelionNULLCompleted2 Years12 YearsBoth36Phase 3United States;France;Germany;Italy;Netherlands;Switzerland;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2004-000745-37-IT
(EUCTR)
15/03/200521/06/2005Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension)Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension) No modification of the label due to the fact that is an open label extension of a phase IV trial.
MedDRA version: 6.1;Level: PT;Classification code 10037406
Trade Name: TRACLEER*125MG 56CPR RIV.
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Spain;Italy
82EUCTR2004-000478-30-ES
(EUCTR)
10/02/200503/11/2004Endothelin 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
83EUCTR2004-000478-30-BE
(EUCTR)
14/12/200424/08/2005Endothelin 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
84EUCTR2004-000478-30-AT
(EUCTR)
08/12/200403/11/2004Endothelin 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
85EUCTR2004-000478-30-CZ
(EUCTR)
26/11/200426/11/2004Endothelin 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
86EUCTR2004-000478-30-SE
(EUCTR)
28/10/200420/07/2004Endothelin 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
87EUCTR2004-000745-37-ES
(EUCTR)
11/10/200407/10/2004Uncontrolled 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
88EUCTR2004-000478-30-DK
(EUCTR)
10/09/200410/01/2007Endothelin 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: 9.1;Level: LLT;Classification code 10064911;Term: 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
89EUCTR2004-000478-30-IT
(EUCTR)
09/09/200411/07/2007A randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of bosentan in patients with mildly symptomatic pulmonary arterial hypertension. - EARLYA 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 Treatment of pulmonary arterial hypertension (PAH) in patients with grade II modified NYHA
MedDRA version: 14.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: TRACLEER*56CPR RIV 125MG
INN or Proposed INN: Bosentan
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
170Czech Republic;Spain;Denmark;United Kingdom;Italy;Sweden
90NCT00120380
(ClinicalTrials.gov)
September 200411/7/2005Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial HypertensionHypertensionDrug: Aerosolized iloprost;Drug: PlaceboHannover Medical SchoolNULLTerminated18 Years75 YearsBoth40Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00266162
(ClinicalTrials.gov)
August 200415/12/2005Bosentan in Treatment of Pulmonary Arterial HypertensionTherapy of Pulmonary Arterial Hypertension (PAH) With Bosentan in Patients With Eisenmenger SyndromeEisenmenger SyndromeDrug: Bosentan administrationCompetence Network for Congenital Heart DefectsGerman Federal Ministry of Education and Research;ActelionCompleted18 YearsN/ABoth60Phase 4Germany
92EUCTR2004-000478-30-GB
(EUCTR)
15/07/200421/06/2005 Endothelin 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 Endothelin 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.Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noCzech Republic;Belgium;Spain;Denmark;Austria;Italy;United Kingdom;Sweden
93NCT00086463
(ClinicalTrials.gov)
June 20041/7/2004Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAHPulmonary Arterial Hypertension;Ayerza Syndrome;Pulmonary HypertensionDrug: Iloprost or placeboActelionNULLCompleted12 Years75 YearsBoth60Phase 2United States
94NCT00091715
(ClinicalTrials.gov)
April 200416/9/2004Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class IIA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Bosentan in Patients With Mildly Symptomatic Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: bosentan;Drug: placeboActelionNULLCompleted12 YearsN/ABoth185Phase 3United States;Australia;Austria;Belgium;Canada;China;Czech Republic;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom
95NCT00317486
(ClinicalTrials.gov)
September 200321/4/2006Effects of Tracleer (Bosentan) on Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Tracleer (Bosentan) on Oxygen Saturation and Cardiac Hemodynamics in Patients With Pulmonary Arterial Hypertension Related to Eisenmenger PhysiologyPulmonary Arterial Hypertension Related to Eisenmenger PhysiologyDrug: bosentanActelionNULLCompleted12 YearsN/ABoth54Phase 4United States;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT00082186
(ClinicalTrials.gov)
July 200330/4/2004The Effect of Tracleer® on Male FertilityTRACLEER® (Bosentan) Pulmonary Arterial Hypertension A Multicenter, Open-label, Single-arm Safety Study to Investigate the Effects of Chronic TRACLEER® Treatment on Testicular Function in Male Patients With Pulmonary Arterial HypertensionHypertension, PulmonaryDrug: bosentanActelionNULLCompleted18 Years65 YearsMale22Phase 4United States;Australia;Brazil;Czech Republic;Hungary
97NCT00080457
(ClinicalTrials.gov)
May 20031/4/2004Safety and Efficacy Study of Sitaxentan Sodium (Thelin™) in Patients With Pulmonary Arterial HypertensionA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Sitaxsentan Sodium (Thelin™) Treatment With an Open-Label Bosentan Arm in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionDrug: sitaxsentan sodiumEncysive PharmaceuticalsNULLCompleted12 Years75 YearsBoth240Phase 3United States
98EUCTR2010-021793-12-FR
(EUCTR)
04/02/2011A prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extensionA prospective, multicenter, open-label extension of FUTURE 3 to assess thesafety, tolerability and efficacy of the pediatric formulation of bosentan twoversus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
64Phase 3France;Czech Republic;Hungary;Poland;Spain;Netherlands;Germany;Italy
99EUCTR2010-021793-12-PL
(EUCTR)
25/07/2011A 1 year follow-up research project for children with pulmonary arterial hypertension (PAH) that participated in the FUTURE 3 core study. This is to find out how well bosentan is tolerated and safe when taken either two or three times a dayA prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 study extension Pulmonary arterial hypertension (PAH) in children
MedDRA version: 14.0;Level: LLT;Classification code 10064908;Term: Associated with (APAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
64Phase 3Serbia;United States;Belarus;Spain;Ukraine;Israel;Russian Federation;Italy;India;France;Czech Republic;Hungary;Mexico;Poland;South Africa;Netherlands;Germany;China
100EUCTR2005-005068-97-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2005-001967-70-DE
(EUCTR)
30/08/2005An 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
102EUCTR2011-004612-31-NL
(EUCTR)
07/05/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
103EUCTR2010-021825-11-FR
(EUCTR)
13/12/2010An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 12.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH)
MedDRA version: 12.1;Classification code 10064909;Term: Idiopathic (IPAH)
MedDRA version: 12.1;Classification code 10064910;Term: Familial (FPAH)
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: BOSENTAN MONOHYDRATE
Other descriptive name: Ro-47-0203/029
Actelion Pharmaceuticals Ltd.NULLNAFemale: yes
Male: yes
64Phase 3France;Czech Republic;Hungary;Spain;Bulgaria;Germany;Netherlands;Italy
104EUCTR2011-004106-16-FR
(EUCTR)
17/02/2012A 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 compoundA 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 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China
105EUCTR2011-004106-16-NL
(EUCTR)
10/02/2012A 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 compoundA 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 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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Guatemala;Ukraine;Russian Federation;Chile;Colombia;India;Vietnam;France;Mexico;Argentina;Croatia;Peru;South Africa;Bulgaria;Netherlands;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2011-004612-31-FR
(EUCTR)
27/08/2012A 12-month research project for children who have gone through the FUTURE 5 research project and who want to continue treatment to see how well bosentan is tolerated when administered over a long period of time.A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6 Pulmonary arterial hypertension (PAH) in children
MedDRA version: 15.0;Level: LLT;Classification code 10064910;Term: Familial (FPAH);System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 15.0;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]
Trade Name: Tracleer
Product Name: bosentan
INN or Proposed INN: bosentan
Other descriptive name: BOSENTAN MONOHYDRATE
Actelion pharmaceuticals LtdNULLNAFemale: yes
Male: yes
105Phase 3Portugal;Serbia;United States;Philippines;Taiwan;Guatemala;Ukraine;Chile;Russian Federation;Colombia;India;Vietnam;France;Mexico;Argentina;Malaysia;Singapore;Croatia;Peru;Bulgaria;South Africa;Netherlands;China