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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-001699-12-GB (EUCTR) | 27/08/2019 | 30/07/2019 | Relative bioavailability study of marketed and lower dose ambrisentan in healthy adult participants | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 1 | United Kingdom | ||
| 2 | EUCTR2014-001882-28-DE (EUCTR) | 13/10/2014 | 07/08/2014 | Drug treatment of patients with systemic sclerosis to prevent deterioration of pulmonary hypertension | Early 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 gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 38 | Phase 2 | Germany | ||
| 3 | EUCTR2010-021572-29-IT (EUCTR) | 19/09/2011 | 07/02/2011 | 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 - AMB114588 | 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 - 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Greece;Spain;Netherlands;Germany;Italy | |||
| 4 | EUCTR2010-021572-29-NL (EUCTR) | 19/07/2011 | 11/11/2010 | 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 | 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 | 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, Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | |||
| 5 | EUCTR2010-021572-29-ES (EUCTR) | 19/01/2011 | 17/11/2010 | 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. | 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.A | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Greece;Spain;Netherlands;Germany;Italy | |||
| 6 | EUCTR2010-021572-29-DE (EUCTR) | 11/01/2011 | 10/11/2010 | 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 | 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 | 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 3 | France;Hungary;Greece;Spain;Netherlands;Germany;Italy | ||
| 7 | EUCTR2010-021572-29-HU (EUCTR) | 10/01/2011 | 22/11/2010 | 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 | 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 | 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, Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | |||
| 8 | NCT01406327 (ClinicalTrials.gov) | December 14, 2010 | 28/7/2011 | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Drug Use Investigation for VOLIBRIS® (Ambrisentan) (Pulmonary Arterial Hypertension) | Hypertension, Pulmonary | Drug: Ambrisentan | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 900 | NULL | |
| 9 | EUCTR2010-019547-19-IT (EUCTR) | 30/11/2010 | 14/12/2010 | 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 - AMB112529 | 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 - 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | |||
| 10 | EUCTR2010-021572-29-GR (EUCTR) | 23/11/2010 | 26/10/2010 | 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 | 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 | 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;Spain;Italy;Greece | |||
| 11 | EUCTR2009-011150-17-BE (EUCTR) | 15/11/2010 | 14/06/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 614 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 12 | EUCTR2010-019547-19-FR (EUCTR) | 12/11/2010 | 23/08/2010 | 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. | 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, Ltd | NULL | Not 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): no | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 13 | EUCTR2010-019547-19-NL (EUCTR) | 05/11/2010 | 01/07/2010 | 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. | 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 14 | EUCTR2010-019547-19-HU (EUCTR) | 15/10/2010 | 12/07/2010 | 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. | 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 15 | EUCTR2010-019547-19-ES (EUCTR) | 06/10/2010 | 15/07/2010 | 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. | NULL | Not 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): no | France;Hungary;Greece;Spain;Germany;Netherlands;Italy | ||
| 16 | EUCTR2010-019547-19-DE (EUCTR) | 05/10/2010 | 14/07/2010 | 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. | 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | France;Hungary;Greece;Spain;Netherlands;Germany;Italy | ||
| 17 | EUCTR2009-011150-17-FR (EUCTR) | 24/09/2010 | 13/08/2010 | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: 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 Limited | NULL | Not 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): yes | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 18 | EUCTR2009-011150-17-NL (EUCTR) | 26/08/2010 | 26/05/2010 | Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension | 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] - 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | Phase 4 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Japan;Sweden | ||
| 19 | EUCTR2009-011150-17-DE (EUCTR) | 16/08/2010 | 03/08/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 614 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Germany;Netherlands;Japan;Sweden | |||
| 20 | EUCTR2009-011150-17-GB (EUCTR) | 11/08/2010 | 22/06/2010 | Study 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 Ltd | NULL | Not 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): yes | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 21 | EUCTR2009-011150-17-IT (EUCTR) | 06/08/2010 | 09/08/2010 | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | AMBITION: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
| 22 | EUCTR2009-011150-17-AT (EUCTR) | 03/08/2010 | 22/06/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 23 | EUCTR2009-011150-17-GR (EUCTR) | 16/07/2010 | 14/07/2010 | AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION | 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: 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 24 | EUCTR2010-019547-19-GR (EUCTR) | 16/07/2010 | 30/06/2010 | 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. | 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, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 66 | Hungary;Germany;Netherlands;France;Spain;Italy;Greece | |||
| 25 | EUCTR2009-011150-17-SE (EUCTR) | 14/07/2010 | 18/06/2010 | Study 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 545 | United States;Greece;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Japan;Sweden | |||
| 26 | EUCTR2009-011150-17-ES (EUCTR) | 13/07/2010 | 02/06/2010 | AMBITION: 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 | AMBITION: 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. | NULL | Not Recruiting | Female: yes Male: yes | 352 | France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
| 27 | EUCTR2010-019547-19-Outside-EU/EEA (EUCTR) | 16/03/2012 | Testing 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 Limited | NULL | NA | Female: yes Male: yes | 66 | Russian Federation;United States;Argentina;Brazil;Canada;Japan;Mexico | ||||
| 28 | EUCTR2010-021572-29-FR (EUCTR) | 11/10/2011 | Testing 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | United States;France;Hungary;Greece;Spain;Netherlands;Germany;Italy;Japan |