88. 慢性血栓塞栓性肺高血圧症 Chronic thromboembolic pulmonary hypertension Clinical trials / Disease details
臨床試験数 : 157 / 薬物数 : 107 - (DrugBank : 22) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 54
| 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 | EUCTR2005-002900-40-GB (EUCTR) | 28/04/2006 | 27/02/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2005-002900-40-CZ (EUCTR) | 13/03/2006 | 13/03/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Czech Republic;Spain;Italy | |||
| 3 | EUCTR2005-002900-40-DE (EUCTR) | 03/03/2006 | 23/01/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: TRACLEER Trade Name: Tracleer Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: BOSENTAN Other descriptive name: TRACLEER | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Germany;Italy;United Kingdom | |||
| 4 | EUCTR2005-002900-40-IT (EUCTR) | 23/01/2006 | 17/01/2007 | LONG-TERM OPEN-LABEL STUDY IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH WHO COMPLETED THE PROTOCOL AC-052-366/BENEFIT. | LONG-TERM OPEN-LABEL STUDY IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH WHO COMPLETED THE PROTOCOL AC-052-366/BENEFIT. | Treatment of inoperable chronic thronboembolic pulmonary hypertension. MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: TRACLEER*56CPR RIV 125MG INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;United Kingdom;Germany;Spain;Italy | |||
| 5 | EUCTR2005-002900-40-BE (EUCTR) | 18/01/2006 | 09/01/2006 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate Product Name: bosentan Product Code: Ro 47-0203 INN or Proposed INN: bosentan monohydrate | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom | |||
| 6 | NCT00319111 (ClinicalTrials.gov) | January 2006 | 26/4/2006 | Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Long-term Open-label Extension Study in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Who Completed Protocol AC-052-366 (BENEFIT, NCT00313222) | Pulmonary Hypertension | Drug: bosentan | Actelion | NULL | Completed | 18 Years | 80 Years | All | 151 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 7 | EUCTR2005-001965-33-AT (EUCTR) | 15/12/2005 | 11/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Spain;Austria;Germany;Italy;United Kingdom | |||
| 8 | EUCTR2005-001965-33-CZ (EUCTR) | 16/11/2005 | 12/10/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Phase 3 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 9 | EUCTR2005-001965-33-GB (EUCTR) | 04/11/2005 | 31/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2005-001965-33-DE (EUCTR) | 01/11/2005 | 29/08/2005 | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel group study to assess the efficacy, safety and tolerability of bosentan in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - BENEFIT | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) MedDRA version: 8.1;Level: LLT;Classification code 10037436;Term: Pulmonary thromboembolism | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 11 | EUCTR2005-001965-33-IT (EUCTR) | 20/10/2005 | 25/01/2006 | PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF BOSENTAN IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH . | PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF BOSENTAN IN PATIENTS WITH INOPERABLE CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION CTEPH . | Treatment of the inoperable chronic thromboembolic pulmonary hypertension MedDRA version: 6.1;Level: PT;Classification code 10037400 | Trade Name: TRACLEER 125MG 56CPR RIV. INN or Proposed INN: Bosentan | ACTELION PHARMACEUTICALS ITALIA | NULL | Not Recruiting | Female: yes Male: yes | 128 | United Kingdom;Germany;Spain;Italy | |||
| 12 | NCT00313222 (ClinicalTrials.gov) | October 2005 | 10/4/2006 | Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension | Prospective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) | Chronic Thromboembolic Pulmonary Hypertension | Drug: bosentan | Actelion | NULL | Completed | 18 Years | 80 Years | Both | 157 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 13 | EUCTR2005-002900-40-AT (EUCTR) | 15/08/2005 | 07/11/2005 | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OL | Inoperable chronic thromboembolic pulmonary hypertension (CTEPH) | 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 | Actelion Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 128 | Czech Republic;Spain;Austria;Germany;Italy;United Kingdom |