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

  
10 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2005-002900-40-GB
(EUCTR)
28/04/200627/02/2006 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.NULLNot 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): noCzech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom
2EUCTR2005-002900-40-CZ
(EUCTR)
13/03/200613/03/2006BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OLBENEFIT-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.NULLNot RecruitingFemale: yes
Male: yes
128United Kingdom;Germany;Czech Republic;Spain;Italy
3EUCTR2005-002900-40-DE
(EUCTR)
03/03/200623/01/2006BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OLBENEFIT-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.NULLNot RecruitingFemale: yes
Male: yes
128Czech Republic;Spain;Germany;Italy;United Kingdom
4EUCTR2005-002900-40-IT
(EUCTR)
23/01/200617/01/2007LONG-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 ITALIANULLNot RecruitingFemale: yes
Male: yes
128Czech Republic;United Kingdom;Germany;Spain;Italy
5EUCTR2005-001965-33-AT
(EUCTR)
15/12/200511/10/2005Prospective, 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) - BENEFITProspective, 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.NULLNot RecruitingFemale: yes
Male: yes
128Spain;Austria;Germany;Italy;United Kingdom
6EUCTR2005-001965-33-CZ
(EUCTR)
16/11/200512/10/2005Prospective, 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) - BENEFITProspective, 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.NULLNot RecruitingFemale: yes
Male: yes
128Phase 3Czech Republic;Spain;Austria;Germany;Italy;United Kingdom
7EUCTR2005-001965-33-GB
(EUCTR)
04/11/200531/08/2005Prospective, 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) - BENEFITProspective, 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.NULLNot 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): noCzech Republic;Spain;Austria;Germany;Italy;United Kingdom
8EUCTR2005-001965-33-DE
(EUCTR)
01/11/200529/08/2005Prospective, 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) - BENEFITProspective, 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.NULLNot RecruitingFemale: yes
Male: yes
128United Kingdom;Germany;Spain;Italy
9EUCTR2005-001965-33-IT
(EUCTR)
20/10/200525/01/2006PROSPECTIVE, 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 ITALIANULLNot RecruitingFemale: yes
Male: yes
128United Kingdom;Germany;Spain;Italy
10EUCTR2005-002900-40-AT
(EUCTR)
15/08/200507/11/2005BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocolAC-052-366/BENEFIT - BENEFIT-OLBENEFIT-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.NULLNot RecruitingFemale: yes
Male: yes
128Czech Republic;Spain;Austria;Germany;Italy;United Kingdom