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 | EUCTR2008-003572-21-ES (EUCTR) | 15/01/2009 | 15/10/2008 | Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION | Estudio en fase 2a, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para investigar la respuesta a la dosis de PF-00489791 sobre la hemodinamia a corto plazo en sujetos con hipertensión arterial pulmonar idiopática y familiarA PHASE 2A, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED,PARALLEL GROUP STUDY INVESTIGATING THE DOSE-RESPONSE OFPF-00489791 ON ACUTE HEMODYNAMICS IN SUBJECTS WITH IDIOPATHICAND FAMILIAL PULMONARY ARTERIAL HYPERTENSION | Hipertensión arterial pulmonarPulmonary arterial hypertension. MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension | Product Name: PF-00489791 Product Name: PF-00489791 Product Name: PF-00489791 Trade Name: REVATIO 20 mg, comprimidos recubiertos con película INN or Proposed INN: SILDENAFILO Other descriptive name: SILDENAFIL | Pfizer, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 79 | Phase 2 | Belgium;Spain;Germany;Sweden | ||
| 2 | EUCTR2005-005068-97-ES (EUCTR) | 11/05/2008 | 03/03/2008 | 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 studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | 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 studyEfectos de la combinación de bosentan y sildenafilo frente a sildenafilo en monoterapia sobre la morbimortalidad en pacientes sintomáticos con hipertensión arterial pulmonar – Estudio de fase IV, multicéntrico, en doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, prospectivo y basado en acontecimientos. - COMPASS 2 | Hipertensión Arterial PulmonarPatients to be included must have PAH belonging to WHO Group I, in agreement with the approved indications for sildenafil in PAH by the US FDA:a.Idiopathic (IPAH)b.Familial (FPAH)c.Associated with (APAH):i.Collagen vascular disease with normal left ventricular function (ejection fraction (EF) > 50%) ii.Congenital systemic-to-pulmonary shunts at least 2 years post surgical repairiii.Drugs and toxins MedDRA version: 9.1;Level: LLT;Classification code 10064908;Term: Associated with (APAH) MedDRA version: 9.1;Classification code 10064910;Term: Familial (FPAH) MedDRA version: 9.1;Classification code 10064909;Term: | Trade Name: Tracleer Product Name: bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 Trade Name: Tracleer Product Name: Bosentan Product Code: Ro-47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: Ro-47-0203 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 4 | Portugal;Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2005-006192-13-ES (EUCTR) | 09/06/2006 | 12/05/2006 | Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION | Estudio aleatorio, doble-ciego, controlado con placebo para evaluar la seguridad y eficacia de la adición de Iloprost inhalado en pacientes con hipertensión arterial pulmonar que reciben Sildenafilo por vía oral - VISION | Spanish: hipertensión arterial pulmonar English: Pulmonary Arterial Hypertension (PAH) is a condition that is characterized by increased pulmonary arterial pressure and vascular resistance that can lead to right ventricular failure and death. MedDRA version: 8.1;Classification code 10037400 | Trade Name: **Comment**- IMP inhalation solution identical to ventavis inhalation solution, but IMP is in a different volume presentation. Please see covering letter. Product Name: Iloprost (Ventavis®) INN or Proposed INN: Iloprost | CoTherix, Inc | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Portugal;Spain;Austria;Germany;Italy;United Kingdom |