86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details
臨床試験数 : 1,181 / 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
| 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 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | Hungary;Greece;Spain;Netherlands;Germany;Italy | |||
| 5 | 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 | |||
| 6 | 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 | |||
| 7 | 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 | |||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | |||
| 14 | NCT00554619 (ClinicalTrials.gov) | February 2008 | 5/11/2007 | A Study to Evaluate GSK1325760A - a Long-Term Extension Study | Study AMB107818, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open Label Study of GSK1325760A to Evaluate the Safety and Efficacy of GSK1325760A - a Long-term Extension Study - | Pulmonary Arterial Hypertension;Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | NULL | Completed | N/A | N/A | All | 21 | Phase 3 | Japan |
| 15 | NCT00540436 (ClinicalTrials.gov) | August 2007 | 5/10/2007 | Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension | Study AMB107816, Clinical Evaluation of GSK1325760A in the Treatment of Pulmonary Arterial Hypertension (PAH)- An Open-Label Phase II/III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of GSK1325760A - | Hypertension, Pulmonary | Drug: GSK1325760A | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 25 | Phase 2 | Japan |
| 16 | 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 | |||
| 17 | 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 |