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 | EUCTR2005-000963-25-SK (EUCTR) | 20/04/2007 | 20/03/2007 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 8.1;Level: LLT;Classification code 10064911 | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 185 | Phase 3 | Slovakia;Finland;United Kingdom;Sweden | ||
| 2 | EUCTR2005-000963-25-FI (EUCTR) | 28/03/2007 | 09/01/2007 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 8.1;Level: LLT;Classification code 10064911 | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 185 | Finland;United Kingdom;Sweden | |||
| 3 | EUCTR2006-002235-25-FI (EUCTR) | 28/03/2007 | 09/01/2007 | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911 | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 204 | Finland;United Kingdom | |||
| 4 | EUCTR2006-002235-25-SK (EUCTR) | 22/03/2007 | 13/02/2007 | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911 | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | Slovakia;Finland;United Kingdom | ||
| 5 | EUCTR2006-002235-25-GB (EUCTR) | 14/12/2006 | 18/09/2006 | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | Pulmonary Arterial Hypertension MedDRA version: 9.0;Level: LLT;Classification code 10064911 | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovakia;Finland;United Kingdom | ||
| 6 | EUCTR2005-000963-25-GB (EUCTR) | 13/09/2006 | 19/09/2006 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 8.1;Level: LLT;Classification code 10064911 | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Finland;United Kingdom;Sweden | ||
| 7 | EUCTR2005-000963-25-SE (EUCTR) | 30/05/2005 | 06/04/2005 | Oral Revatio in Pediatric PAH- Long term follow on study to A1481131 | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | Not Recruiting | Female: yes Male: yes | 200 | Taiwan;Finland;Thailand;Costa Rica;Guatemala;Chile;Russian Federation;Colombia;United Kingdom;Italy;India;Hungary;Mexico;Brazil;Malaysia;Poland;Sweden | |||
| 8 | EUCTR2005-000963-25-Outside-EU/EEA (EUCTR) | 07/03/2012 | Oral Revatio in Pediatric PAH - Long-term follow-on Study to A1481131. | A Multicenter, Long-Term Extension Study to Assess Safety of Oral Sildenafil in the Treatment of Subjects Who Have Completed Study A1481131 - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Limited, Ramsgate Road, Sandwich, Kent, UK | NULL | NA | Female: yes Male: yes | 220 | Russian Federation;Taiwan;United States;Brazil;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico | ||||
| 9 | EUCTR2006-002235-25-Outside-EU/EEA (EUCTR) | 07/03/2012 | A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension | A Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Parallel Group Study of Oral Sildenafil in the Treatment of Children, Aged 1-17 Years, With Pulmonary Arterial Hypertension - N/A | Pulmonary Arterial Hypertension MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 Product Name: Sildenafil Citrate Product Code: UK-92,480-10 INN or Proposed INN: sildenafil (as citrate) Other descriptive name: UK-92,480 | Pfizer Ltd, Ramsgate Rd, Sandwich, Kent, United Kingdom | NULL | NA | Female: yes Male: yes | 235 | Brazil;Canada;Chile;Colombia;Guatemala;India;Japan;Malaysia;Mexico;Peru;Russian Federation;Taiwan;United States | ||||
| 10 | EUCTR2005-005068-97-DE (EUCTR) | 13/02/2006 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Effects of combination of bosentan and sildenafil versus sildenafil monotherapy on morbidity and mortality in symptomatic patients with pulmonary arterial hypertension – A multicenter, double - blind, randomized, placebo - controlled, parallel group, prospective, event driven Phase IV study - COMPASS 2 | Patients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064909;Term: Idiopathic (IPAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: bosentan monohydrate Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil (as citrate) Trade Name: Viagra INN or Proposed INN: sildenafil Trade Name: Revatio INN or Proposed INN: sildenafil (as citrate) | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 4 | Portugal;Czech Republic;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden |