86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

  
28 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-001699-12-GB
(EUCTR)
27/08/201930/07/2019Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participantsAn open-label, randomized three period cross-over relative bioavailability study to compare the pharmacokinetic parameters of a lower dose formulation of ambrisentan (GSK1325760) with marketed ambrisentan in healthy adult participants Pulmonary arterial hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ambrisentan Tablet
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
Trade Name: Volibris
Product Name: Ambrisentan 5mg film-coated tablets [marketed product]
INN or Proposed INN: AMBRISENTAN
Other descriptive name: (S)-2-(4,6-dimethylpyrimidin-2-yloxy)-3-methoxy-3,3-diphenylpropanoic acid
GlaxoSmithKline Research and Development LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 1United Kingdom
2EUCTR2014-001882-28-DE
(EUCTR)
13/10/201407/08/2014Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertensionEarly Treatment of Borderline Pulmonary Arterial Hypertension Associated with Systemic Sclerosis (SSc-APAH) - EDITA Systemic sclerosis-patients (SSc) with borderline pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Volibris
Product Name: Ambrisentan
Thoraxklinik-Heidelberg gGmbHNULLNot RecruitingFemale: yes
Male: yes
38Phase 2Germany
3EUCTR2010-021572-29-IT
(EUCTR)
19/09/201107/02/2011An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - AMB114588 Pulmonary Arterial Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064908
MedDRA version: 9.1;Classification code 10064910
MedDRA version: 9.1;Classification code 10064909
Trade Name: VOLIBRIS
INN or Proposed INN: ambrisentan
Trade Name: VOLIBRIS
INN or Proposed INN: ambrisentan
INN or Proposed INN: Ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
4EUCTR2010-021572-29-NL
(EUCTR)
19/07/201111/11/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
5EUCTR2010-021572-29-ES
(EUCTR)
19/01/201117/11/2010Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired.Estudio de extensión abierto y a largo plazo sobre el tratamiento de la hipertensión arterial pulmonar en pacientes pediátricos de 8 a 18 años de edad que han participado en el estudio AMB112529 y para los que se desea tratamiento continuo con ambrisentan.An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired. Hipertensión Arterial PulmonarPulmonary Arterial Hypertension
MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
MedDRA version: 13;Level: PT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline, S.ANULLNot RecruitingFemale: yes
Male: yes
66Hungary;Greece;Spain;Netherlands;Germany;Italy
6EUCTR2010-021572-29-DE
(EUCTR)
11/01/201110/11/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 16.0;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 3France;Hungary;Greece;Spain;Netherlands;Germany;Italy
7EUCTR2010-021572-29-HU
(EUCTR)
10/01/201122/11/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
8NCT01406327
(ClinicalTrials.gov)
December 14, 201028/7/2011Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension)Hypertension, PulmonaryDrug: AmbrisentanGlaxoSmithKlineNULLCompletedN/AN/AAll900NULL
9EUCTR2010-019547-19-IT
(EUCTR)
30/11/201014/12/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years - AMB112529 pulmonary arterial hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911
MedDRA version: 9.1;Classification code 10065150
MedDRA version: 9.1;Classification code 10065151
MedDRA version: 9.1;Classification code 10065152
Trade Name: VOLIBRIS
INN or Proposed INN: AMBRISENTAN
Trade Name: VOLIBRIS
INN or Proposed INN: AMBRISENTAN
Product Name: AMBRISENTAN
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66France;Hungary;Greece;Spain;Germany;Netherlands;Italy
10EUCTR2010-021572-29-GR
(EUCTR)
23/11/201026/10/2010An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desiredAn open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;Spain;Italy;Greece
11EUCTR2009-011150-17-BE
(EUCTR)
15/11/201014/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 16.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
12EUCTR2010-019547-19-FR
(EUCTR)
12/11/201023/08/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
13EUCTR2010-019547-19-NL
(EUCTR)
05/11/201001/07/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
14EUCTR2010-019547-19-HU
(EUCTR)
15/10/201012/07/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Product Name: ambrisentan
Product Code: GSK1325760
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Germany;Netherlands;Italy
15EUCTR2010-019547-19-ES
(EUCTR)
06/10/201015/07/2010 Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Estudio abierto, aleatorizado, para comparar parámetros de seguridad y eficacia para una dosis alta y una baja de ambrisentan (ajustadas al peso corporal), como tratamiento para la hipertensión arterial pulmonar en pacientes pediátricos entre 8 y 18 años. A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Hipertensión arterial pulmonar
MedDRA version: 13;Level: LLT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 13;Level: PT;Classification code 10065150;Term: Hipertensión pulmonar arterial primaria asociada
MedDRA version: 13;Classification code 10065151;Term: Hipertensión pulmonar arterial primaria idiopática
MedDRA version: 13;Classification code 10065152;Term: Hipertensión pulmonar arterial primaria familiar
Trade Name: VOLIBRIS 10 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
GlaxoSmithKline, S.A.NULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Hungary;Greece;Spain;Germany;Netherlands;Italy
16EUCTR2010-019547-19-DE
(EUCTR)
05/10/201014/07/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. 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
MedDRA version: 14.1;Level: LLT;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Phase 2France;Hungary;Greece;Spain;Netherlands;Germany;Italy
17EUCTR2009-011150-17-FR
(EUCTR)
24/09/201013/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
352 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
18EUCTR2009-011150-17-NL
(EUCTR)
26/08/201026/05/2010Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial HypertensionAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545Phase 4France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden
19EUCTR2009-011150-17-DE
(EUCTR)
16/08/201003/08/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
614United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden
20EUCTR2009-011150-17-GB
(EUCTR)
11/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot Recruiting Female: yes
Male: yes
545 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
21EUCTR2009-011150-17-IT
(EUCTR)
06/08/201009/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Trade Name: VOLIBRIS
Trade Name: CIALIS
INN or Proposed INN: Tadalafil
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
22EUCTR2009-011150-17-AT
(EUCTR)
03/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
23EUCTR2009-011150-17-GR
(EUCTR)
16/07/201014/07/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
24EUCTR2010-019547-19-GR
(EUCTR)
16/07/201030/06/2010A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years.A randomized, open label study comparing safety and efficacy parameters for a high and a low dose of ambrisentan (adjusted for body weight) for the treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years. Pulmonary Arterial Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension
MedDRA version: 12.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: ambrisentan
GlaxoSmithKline Research & Development, LtdNULLNot RecruitingFemale: yes
Male: yes
66Hungary;Germany;Netherlands;France;Spain;Italy;Greece
25EUCTR2009-011150-17-SE
(EUCTR)
14/07/201018/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
545United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden
26EUCTR2009-011150-17-ES
(EUCTR)
13/07/201002/06/2010AMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: Estudio multicéntrico aleatorizado del tratamiento combinado de primera línea con ambrisentán y tadalafilo en sujetos con hipertensión arterial primariaAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Hipertensión arterial pulmonar
MedDRA version: 11;Level: PT;Classification code 10064911;Term: Hipertensión arterial pulmonar
MedDRA version: 11;Level: LLT;Term: Hipertensión arterial pulmonar
Trade Name: VOLIBRIS 5 mg comprimidos recubiertos con película
INN or Proposed INN: AMBRISENTAN
Other descriptive name: AMBRISENTAN
Trade Name: CIALIS 20 mg comprimidos recubiertos con película
INN or Proposed INN: TADALAFILO
Other descriptive name: TADALAFIL
GlaxoSmithKline,S.A.NULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
27EUCTR2010-019547-19-Outside-EU/EEA
(EUCTR)
16/03/2012Testing medicines to treat children with pulmonary arterial hypertension(PAH)A randomized, open label study comparing safety and efficacyparameters for a high and a low dose of ambrisentan (adjustedfor body weight) for the treatment of pulmonary arterialhypertension in paediatric patients aged 8 years up to 18 years. - Efficacy and Safety of Ambrisentan in Children 8-17yrs 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
MedDRA version: 14.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
Trade Name: VOLIBRIS™ tablets
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: VOLIBRIS
GlaxoSmithKline Research & Development LimitedNULLNAFemale: yes
Male: yes
66Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico
28EUCTR2010-021572-29-FR
(EUCTR)
11/10/2011Testing medicines to treat children with pulmonary arterial hypertension (PAH)Testing medicines to treat teens with pulmonary arterial hypertension (PAH)An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired - Safety FU Study of Amb in 8-17yr olds Pulmonary Arterial Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension;Classification code 10065152;Term: Familial pulmonary arterial hypertension;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: VOLIBRIS® (ambrisentan)
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Trade Name: VOLIBRIS® (ambrisentan)
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Product Name: ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan