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 | EUCTR2007-003621-24-AT (EUCTR) | 30/03/2009 | 23/04/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 2 | EUCTR2007-003621-24-GB (EUCTR) | 02/12/2008 | 14/07/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 3 | EUCTR2007-003621-24-NL (EUCTR) | 23/07/2008 | 13/03/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 4 | EUCTR2007-003621-24-IT (EUCTR) | 15/07/2008 | 17/11/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension - ND | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10065150;Term: Associated with pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil | MONDOGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 5 | EUCTR2007-003621-24-ES (EUCTR) | 07/07/2008 | 12/05/2008 | Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar. | Estudio doble ciego, aleatorizado, controlado por placebo, de determinación de dosis, de grupos paralelos, para valorar los efectos hemodinámicos, la eficacia clínica, la tolerabilidad y la seguridad de Aviptadil (Péptido intestinal Vasoactivo) tras una inhalación, e inhalaciones repetidas, en pacientes con hipertensión arterial pulmonar. | Hipertensión arterial pulmonar (HAP) debida a hipertensión arterial pulmonar idiopática (HAPI), HAP familiar o HAP asociada con enfermedades del tejido conjuntivo (ETC) (p. ej. esclerosis sistémica, lupus eritematoso sistémico) o con defectos cardiacos congénitos reparados(DCCR). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 6 | EUCTR2007-003621-24-BE (EUCTR) | 20/06/2008 | 08/01/2008 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | France;Spain;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 7 | EUCTR2007-003621-24-FR (EUCTR) | 29/05/2008 | 27/12/2007 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria | |||
| 8 | EUCTR2007-003621-24-DE (EUCTR) | 20/03/2008 | 13/02/2009 | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Double-blind, randomized, placebo-controlled, dose-finding, parallel-group study to assess the hemodynamic effects, clinical efficacy, tolerability and safety of Aviptadil (Vasoactive Intestinal Peptide) after single and repeated inhalation in patients with pulmonary arterial hypertension. | Pulmonary arterial hypertension (PAH) due to idiopathic pulmonary arterial hypertension (IPAH), familial PAH or PAH associated with connective tissue diseases (CTD) (e.g. systemic sclerosis, systemic lupus erythematosus) or to repaired congenital heart defects (RCHD). MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065151;Term: Idiopathic pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065152;Term: Familial pulmonary arterial hypertension MedDRA version: 9.1;Classification code 10065150;Term: Associated with pulmonary arterial hypertension | Product Name: Aviptadil Product Code: VIP INN or Proposed INN: Aviptadil Other descriptive name: VIP | MondoGEN AG | NULL | Not Recruiting | Female: yes Male: yes | 48 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria |