88. 慢性血栓塞栓性肺高血圧症
[臨床試験数:145,薬物数:112(DrugBank:22),標的遺伝子数:13,標的パスウェイ数:52

Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2000032403
2021-01-012020-04-27Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study)Efficacy and safety of refined balloon pulmonary angioplasty combined with riociguat in the treatment of inoperable chronic thromboembolic pulmonary hypertension: a single center, open label, prospective, optimal, randomized, parallel controlled clinical study (PRACTICE study) chronic thromboembolic pulmonary hypertensionRiociguat Group:Riociguat;Riociguat+BPA Group:Riociguat and BPA;Shanghai Pulmonary HospitalNULLPending18BothRiociguat Group:30;Riociguat+BPA Group:30;China
2EUCTR2019-004131-24-GB
(EUCTR)
23/11/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;United Arab Emirates;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
3EUCTR2019-004131-24-LT
(EUCTR)
10/11/202022/09/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;Serbia;Taiwan;Saudi Arabia;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
4JPRN-jRCTs041200052
22/10/202022/10/2020THERAPY-HYBRID-BPA trialThe Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients after Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary Angioplasty. - Riociguat-CTEPH chronic thromboembolic pulmonary hypertension
CTEPH;D000081029
In this study, we will perform continuous verification by allocating the Chronic Thromboembolic Pulmonary Hypertension (CTEPH) patients whose hemodynamics were normalized after Balloon Pulmonary Angioplasty (BPA) to the the riociguat active group and placebo group for 16 weeks.Shimokawahara HirotoNULLRecruiting>= 18age old< 85age oldBoth72Phase 2Japan
5NCT04600492
(ClinicalTrials.gov)
October 16, 202019/10/2020THERAPY-HYBRID-BPA TrialThe Effect of Riociguat for Peak Cardiac Index on Cardiopulmonary Exercise Test in CTEPH Patients After Normalization of Pulmonary Artery Pressure by Combination Treatment of Riociguat and Balloon Pulmonary AngioplastyHypertension, PulmonaryDrug: Riociguat Oral TabletNational Hospital Organization Okayama Medical CenterBayer Yakuhin, Ltd.Recruiting18 Years85 YearsAll72Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-004131-24-DE
(EUCTR)
10/08/202026/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;France;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan;Saudi Arabia;Serbia;United States;United Arab Emirates
7EUCTR2020-001157-48-GB
(EUCTR)
28/07/202009/07/2020PIPAH study: Using imatinib (drug) in Pulmonary Arterial HypertensionIdentifying a safe and tolerated dose of Imatinib forpatients with Pulmonary Arterial Hypertension (PAH) - Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH) Pulmonary Arterial Hypertension (Idiopathic, heritable, or assosicated with anorexigens)
MedDRA version: 21.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10050701;Term: Congenital pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Imatinib mesilate
Product Name: Imatinib mesilate
INN or Proposed INN: Imatinib mesilate
Imperial College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
43Phase 2United Kingdom
8EUCTR2019-004131-24-HU
(EUCTR)
27/07/202028/05/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3Serbia;United States;United Arab Emirates;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
9NCT04271475
(ClinicalTrials.gov)
July 7, 202013/2/2020A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary HypertensionA Prospective, Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel Group, Adaptive Phase 3 Study With Open-label Extension to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary HypertensionChronic Thromboembolic Pulmonary HypertensionDrug: Macitentan;Drug: PlaceboActelionNULLRecruiting18 Years80 YearsAll144Phase 3United States;Argentina;Australia;Austria;Bulgaria;Canada;Colombia;Czechia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Singapore;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom
10EUCTR2019-004131-24-PL
(EUCTR)
02/07/202002/06/2020A Phase 3 study to evaluate whether macitentan 75 mg is an effective and safe treatment for patients with inoperable or persistent chronic thromboembolic pulmonary hypertension.A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH Chronic thromboembolic pulmonary hypertension
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
Product Name: Macitentan tablets
Product Code: JNJ-67896062 / ACT-064992
INN or Proposed INN: MACITENTAN
Other descriptive name: ACT-064992
ACTELION Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
230Phase 3United States;United Arab Emirates;Serbia;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Israel;Russian Federation;Colombia;Italy;Australia;China;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Singapore;Romania;Bulgaria;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-002823-41-AT
(EUCTR)
04/10/201904/04/2019A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden
12EUCTR2018-002823-41-BG
(EUCTR)
17/07/201919/04/2019A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Estonia;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden
13EUCTR2018-002823-41-DK
(EUCTR)
15/07/201926/04/2019A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Thailand;Ukraine;Russian Federation;Israel;Switzerland;Italy;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;Sweden
14EUCTR2018-002823-41-PT
(EUCTR)
18/06/201930/05/2019A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400Phase 3United States;Portugal;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Singapore;Bulgaria;Germany;Sweden
15EUCTR2018-002823-41-DE
(EUCTR)
03/06/201911/09/2018A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR2000034995
2019-06-012020-07-27Real world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapyReal world study on the changes of pulmonary perfusion in patients with chronic thromboembolic pulmonary hypertension treated with percutaneous balloon pulmonary angioplasty versus targeted drug therapy pulmonary hypertensionBPA:BPA;Target Drug:Target Drug;BPA+Target Drug:BPA+Target Drug;The First Affiliated Hospital of Guangzhou Medical UniversityNULLRecruiting2080BothBPA:20;Target Drug:20;BPA+Target Drug:20;N/AChina
17NCT04081012
(ClinicalTrials.gov)
May 21, 201916/8/2019N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Chronic Thromboembolic Pulmonary Hypertension.N-acetyl Cysteine in Post-reperfusion Pulmonary Injury in Patients With Chronic Thromboembolic Pulmonary Hypertension Undergoing Pulmonary Balloon Angioplasty and Pulmonary Endarterectomy.Chronic Thromboembolic Pulmonary HypertensionDrug: N-acetyl cysteine;Drug: PlaceboInstituto Nacional de Cardiologia Ignacio ChavezNULLRecruitingN/AN/AAll34N/AMexico
18EUCTR2018-002823-41-NL
(EUCTR)
30/04/201920/12/2018A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallelgroup, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an addon to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400Phase 3Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Germany;Sweden
19NCT04207593
(ClinicalTrials.gov)
April 1, 201917/12/2019The Effect of Oxygen Therapy on 6MWD in PAH and CTEPH Patients With HypoxemiaProspective, Randomized, Controlled Trial of the Effect of Long-term Oxygen Therapy on 6-minute Walking Distance, Clinical Parameters and Hemodynamics in Patients With PAH and CTEPHOxygen Deficiency;Pulmonary Arterial Hypertension;CTEPHDrug: OxygenHeidelberg UniversityNULLRecruiting18 YearsN/AAll40Phase 2Germany
20NCT03806907
(ClinicalTrials.gov)
April 1, 201915/1/2019Iodine Subtraction Mapping in the Diagnosis of Chronic Pulmonary Thromboembolic DiseaseIodiNe Subtraction maPpIng in the Diagnosis of chRonic Pulmonary thromboEmbolic Disease (INSPIRE): An Observational Diagnostic StudyChronic Thromboembolic Pulmonary HypertensionRadiation: Computed tomography lung subtraction iodine mappingUniversity of SheffieldSheffield Teaching Hospitals NHS Foundation TrustNot yet recruiting18 Years90 YearsAll100NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-002823-41-GB
(EUCTR)
25/03/201918/09/2018A clinical study to assess the efficacy and safety of selexipag as an add-onto standard of care therapy in subjects with inoperable orpersistent/recurrent, after surgical treatment and/or ChronicThromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallelgroup,group-sequential, adaptive, Phase 3 study with open-labelextension period to assess the efficacy and safety of selexipag as an addonto standard of care therapy in subjects with inoperable orpersistent/recurrent after surgical and/or interventional treatment ChronicThromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Taiwan;Estonia;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Bulgaria;Germany;Sweden
22EUCTR2018-002823-41-BE
(EUCTR)
18/03/201920/12/2018A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;Denmark;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Bulgaria;Germany;Sweden;United States;Portugal;Taiwan;Slovakia;Thailand
23EUCTR2018-001387-39-DE
(EUCTR)
15/03/201930/01/2019The effect of oxygen therapy in patients with pulmonary Hypertension.A prospective, randomized, controlled trial to assess the effect of long-term oxygen therapy on 6-minute walking distance, clinical parameters and hemodynamics in patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) - SOPHA pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Thoraxklinik-Heidelberg gGmbHNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20Phase 2Germany
24EUCTR2018-002823-41-HU
(EUCTR)
27/02/201908/01/2019A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment, Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 20.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
400Phase 3Portugal;United States;Hong Kong;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;Brazil;Singapore;Bulgaria;Germany;Sweden
25EUCTR2018-002823-41-CZ
(EUCTR)
22/02/201901/11/2018A clinical study to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent, after surgical treatment and/or Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension. - SELECT Chronic Thromboembolic Pulmonary Hypertension, inoperable or persistent/recurrent
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Uptravi
Product Name: Selexipag
Product Code: ACT-293987
INN or Proposed INN: SELEXIPAG
Actelion Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3Portugal;United States;Taiwan;Slovakia;Thailand;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;Australia;Denmark;South Africa;Netherlands;China;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03689244
(ClinicalTrials.gov)
January 23, 201927/9/2018A Study to Find Out if Selexipag is Effective and Safe in Patients With Chronic Thromboembolic Pulmonary Hypertension When the Disease is Inoperable or Persistent/Recurrent After Surgery and/or Interventional TreatmentA Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study With Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an add-on to Standard of Care Therapy in Subjects With Inoperable or Persistent/Recurrent After Surgical and/or Interventional Treatment Chronic Thromboembolic Pulmonary HypertensionChronic Thromboembolic Pulmonary HypertensionDrug: Selexipag;Drug: PlaceboActelionNULLRecruiting18 Years85 YearsAll280Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Czechia;Denmark;Germany;Hungary;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Russian Federation;Singapore;Slovakia;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;Ukraine;United Kingdom
27NCT03754660
(ClinicalTrials.gov)
January 21, 201923/11/2018This Study Tests the Safety of Inhaled BAY1237592, How the Drug is Tolerated and How it Effects Patients With High Blood Pressure in the Arteries of the Lungs in the Two Different Disease Groups Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH)A Non-randomized Two Part Multi-Center, Open-label, Single Dose Trial With an Escalation Part in Untreated Pulmonary Arterial Hypertension (PAH) and Chronic Thromboembolic Pulmonary Hypertension (CTEPH) Patients (Part A), Followed by a Parallel Group Part in Untreated and Pre-treated Patients With PAH and CTEPH (Part B) to Investigate the Safety, Tolerability and Pharmacodynamics of Inhaled BAY1237592Hypertension, PulmonaryDrug: BAY1237592;Drug: PH-monotherapy;Drug: PH-combination therapy;Procedure: NO gasBayerNULLRecruiting18 Years80 YearsAll60Phase 1Austria;Czechia;Germany;Poland
28NCT03809650
(ClinicalTrials.gov)
January 8, 201910/1/2019A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Drug: macitentan 10 mgActelionEPS Corporation;Imepro Inc.;General Laboratory, BML, Inc.;Mitsubishi Logistics CorporationTerminated18 Years89 YearsAll9Phase 3Japan
29EUCTR2017-001121-40-GB
(EUCTR)
17/09/201805/02/2018A study to assess the effectiveness of Riociguat when it is used in patients who have an operable form of CTEPH. The effectiveness of Riociguat will be studied in those patients prior to undergoing the operation (known as Pulmonary Endarterectomy)A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance - Riociguat in patients with operable CTEPH prior to pulmonary endarterectomy Chronic Thromboembolic Pulmonary Disease (CTEPH)
MedDRA version: 20.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
International CTEPH Association (ICA)NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Germany;United Kingdom
30NCT03273257
(ClinicalTrials.gov)
August 17, 201825/8/2017Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy (PEA Bridging Study)A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular ResistanceChronic Thromboembolic Pulmonary Hypertension;CTEPHDrug: Riociguat;Drug: Placebo;Procedure: Pulmonary endarterectomyInternational CTEPH AssociationNULLTerminated18 Years80 YearsAll14Phase 2United States;France;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-001121-40-DE
(EUCTR)
17/05/201813/02/2018A study to assess the effectiveness of Riociguat when it is used in patients who have an operable form of CTEPH. The effectiveness of Riociguat will be studied in those patients prior to undergoing the operation (known as Pulmonary Endarterectomy)A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance - Riociguat in patients with operable CTEPH prior to pulmonary endarterectomy Chronic Thromboembolic Pulmonary Disease (CTEPH)
MedDRA version: 20.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
International CTEPH Association (ICA)NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Germany;United Kingdom
32EUCTR2017-001121-40-FR
(EUCTR)
11/05/201821/02/2018A study to assess the effectiveness of Riociguat when it is used in patients who have an operable form of CTEPH. The effectiveness of Riociguat will be studied in those patients prior to undergoing the operation (known as Pulmonary Endarterectomy)A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multicentre, Prospective Study to Assess Efficacy of Riociguat in Patients With Operable CTEPH Prior to Pulmonary Endarterectomy With High Preoperative Pulmonary Vascular Resistance - Riociguat in patients with operable CTEPH prior to pulmonary endarterectomy Chronic Thromboembolic Pulmonary Disease (CTEPH)
MedDRA version: 20.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
International CTEPH Association (ICA)NULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;France;Germany;United Kingdom
33NCT03422328
(ClinicalTrials.gov)
April 4, 201830/1/2018A Clinical Study to Investigate the Long-term Safety of the Drug Macitentan in Patients With Pulmonary Hypertension Who Were Previously Treated With Macitentan in Clinical Studies.mUlticenter, Single-arM, Open-laBel, Long-teRm Safety Study With macitEntan in Patients With puLmonary Hypertension previousLy Treated With mAcitentan in Clinical Studies (UMBRELLA)Pulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary HypertensionDrug: macitentanActelionNULLEnrolling by invitationN/AN/AAll94Phase 3Belarus;France;Ukraine;Poland
34NCT03074539
(ClinicalTrials.gov)
February 1, 201714/2/2017Sleep-Disordered Breathing in Chronic Thromboembolic Pulmonary HypertensionSleep-Disordered Breathing in Chronic Thromboembolic Pulmonary Hypertension - a Prospective, Descriptive Cohort StudyChronic Thromboembolic Pulmonary Hypertension;Sleep Disordered BreathingDrug: Riociguat;Procedure: Pulmonary Endarteriectomy;Procedure: Ballon Pulmonary AngioplastyMedical University of ViennaNULLRecruiting18 YearsN/AAll50N/AAustria
35EUCTR2016-000347-14-ES
(EUCTR)
16/06/201617/05/2016Comparative study between patients with pulmonary hypertension and healthy subjects detecting pulmonary cell changes by FDG PET imagingCell proliferation in pulmonary hypertension: mollecular imaging detection by FDG PET. Comparative study between patients and healthy subjects Pulmonary artery hypertension and thromboembolic chronic pulmonary hypertension
MedDRA version: 19.0;Level: LLT;Classification code 10037405;Term: Pulmonary hypertension primary;System Organ Class: 100000004855
MedDRA version: 19.0;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: Barnascan
Product Name: BARNASCAN
INN or Proposed INN: FLUDEOXYGLUCOSE
Other descriptive name: FLUDEOXYGLUCOSE
IDIBAPSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36JPRN-JapicCTI-163279
10/6/201601/06/2016A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH)A confirmatory (phase III) study of the efficacy and safety of NS-304 (selexipag) in patients with chronic thromboembolic pulmonary hypertension (CTEPH) Chronic thromboembolic pulmonary hypertension (CTEPH)Intervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
Control intervention name : NS-304 Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Oral administration
Nippon Shinyaku Co., Ltd.NULLcomplete2085BOTH72Phase 3Japan
37JPRN-jRCTs031180239
14/04/201612/03/2019MR BPA studyMulticenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA study Chronic Thromboembolic Pulmonary HypertensionGroup A: BPA treatment
BPA is performed after allocation to this group (initial date of implementation will be the reference date). BPA will be completed within four months of the reference date.

Group B: Riociguat treatment
Riociguat treatment will be initiated after allocation to this group (the initial administration day will be the reference date). Riociguat will be initially administered three times per day at 1.0 mg per dose. Using systolic blood pressure (95 mmHg or higher) as a guide, the dose will be increased by 0.5 mg for each subject every two weeks with a thrice-daily administration of 2.5 mg/dose set as the maximum dosage. Dosage adjustment, including the maintenance dosage, is based on the judgment of the responsible investigators and investigators. Dosage adjustment will be completed within four months of the reference date.
Fukuda KeiichiKawakami TakashiNot Recruiting>= 20age old<= 80age oldBoth60N/AJapan
38JPRN-UMIN000019549
2016/04/0128/10/2015Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension Chronic thromboembolic pulmonary hypertension (CTEPH)Group A: BPA treatment

Basically BPA treatment needs to be
finished within 4 months from the day of first BPA session

Group B: Riociguat treatment

First, starting with riociguat 3 times per day (1.0mg/time). Then increase the dose by 0.5mg every two weeks (with systolic blood pressure 95mmHg or higher).
The maximum dose is 2.5mg per dose (three times per day). Dosage is adjusted accordingly for each patient, and the adjustment is finished within 4 months from the day of starting riociguat.
Keio University School of MedicineNULLRecruiting20years-old80years-oldMale and Female60Not selectedJapan
39JPRN-UMIN000018520
2016/01/0101/01/2016Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertension CTEPH (chronic thromboembolic pulmonary hypertension)Initiation of once-daily Edoxaban(60mg) during 6 months after 2 days discontinuation of warfarinDivision of Cardiovascular Medicine, Department of Internal Medicine Kobe University Graduate School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 4Japan
40NCT02634203
(ClinicalTrials.gov)
January 20168/12/2015Riociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary HypertensionRiociguat Versus Balloon Pulmonary Angioplasty in Non-operable Chronic thromboEmbolic Pulmonary HypertensionChronic Thromboembolic Pulmonary HypertensionProcedure: Balloon Pulmonary Angioplasty (BPA);Drug: RiociguatAssistance Publique - Hôpitaux de ParisBayerRecruiting18 Years80 YearsAll124N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02545465
(ClinicalTrials.gov)
September 15, 20158/9/2015A Study to Understand the Treatment Patterns in Patients With Pulmonary Arterial Hypertension or Chronic Thromboembolic Pulmonary Hypertension During a Switch of Treatment to Adempas in Real-life Clinical PracticeRetrospective Chart Review of Patients With PAH or Inoperable/Persistent/Recurrent CTEPH Who Transition Their PH Treatment to AdempasHypertension, PulmonaryDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompletedN/AN/AAll125N/ABelgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom
42NCT02558582
(ClinicalTrials.gov)
September 201514/9/2015Effect of Exercise Training in Patients With Pulmonary HypertensionEffect of Exercise Training in Arterial and Chronic Thromboembolic Pulmonary Hypertension in Switzerland and Standardization With European CountriesHypertension, PulmonaryBehavioral: respiratory and exercise therapy;Behavioral: respiratory and exercise therapy with supplemental oxygenUniversity of ZurichNULLRecruiting18 YearsN/AAll32N/ASwitzerland
43EUCTR2013-003457-25-LT
(EUCTR)
20/08/201502/06/2015Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China
44EUCTR2013-003457-25-NL
(EUCTR)
29/05/201508/05/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 18.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Germany;Netherlands;China
45JPRN-UMIN000026882
2015/04/0110/04/2017Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension.Effect of oxygen administration on pulmonary vascular resistance and cardiac index in patients with chronic thromboembolic pulmonary hypertension. - Effect of oxygen administration on PVR and CI in CTEPH. chronic thromboembolic pulmonary hypertension.Oxygen administrationDepartment of Cardiology, Hospital Organization Okayama Medical CenterNULLComplete: follow-up continuing20years-oldNot applicableMale and Female100Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03195543
(ClinicalTrials.gov)
March 12, 20158/6/2017Assessment of Blood Coagulation Disorders in Patients With Pulmonary HypertensionAssessment of Blood Coagulation Disorders in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension.Pulmonary Artery Hypertension;Chronic Thromboembolic Pulmonary HypertensionDiagnostic Test: Platelet function analyzer-100;Diagnostic Test: Light transmission aggregometry;Diagnostic Test: Rotational thromboelastometry;Diagnostic Test: Endogenous thrombin potentialNational and Kapodistrian University of AthensNULLRecruiting18 YearsN/AAll60Greece
47EUCTR2013-002950-56-LT
(EUCTR)
18/02/201529/12/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of
48NCT02060721
(ClinicalTrials.gov)
February 20152/1/2014Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary HypertensionMERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Chronic Thromboembolic Pulmonary HypertensionDrug: MacitentanActelionNULLActive, not recruiting18 YearsN/AAll76Phase 2Belgium;China;Czechia;France;Germany;Hungary;Lithuania;Mexico;Poland;Russian Federation;Switzerland;Thailand;Turkey;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Chile;Czech Republic;Italy;Korea, Republic of;Netherlands;South Africa;United States;Vietnam
49EUCTR2013-003457-25-BE
(EUCTR)
22/12/201411/04/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Germany;Netherlands;China
50EUCTR2013-003457-25-GB
(EUCTR)
22/09/201417/04/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;Czechia;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT02021292
(ClinicalTrials.gov)
August 20, 201420/12/2013Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary HypertensionProspective, Randomized, Placebo-controlled, Double-blind, Multicenter, Parallel-group, 24-week Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary HypertensionChronic Thromboembolic Pulmonary HypertensionDrug: Macitentan;Drug: PlaceboActelionNULLCompleted18 Years84 YearsAll80Phase 2Belgium;China;Czechia;France;Germany;Hungary;Korea, Republic of;Lithuania;Mexico;Poland;Russian Federation;Switzerland;Thailand;Turkey;Ukraine;United Kingdom;Austria;Bulgaria;Canada;Chile;Czech Republic;Italy;Netherlands;South Africa;United States;Vietnam
52EUCTR2013-003457-25-DE
(EUCTR)
14/08/201430/04/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;Czechia;Thailand;Ukraine;Lithuania;Austria;Chile;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China
53EUCTR2012-001642-17-IT
(EUCTR)
06/08/201412/09/2013An extension study of a drug to treat Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) Subjects with inoperable Chronic Thromboembolic PulmonaryHypertension (CTEPH)
MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: Ambrisentan
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: Ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United States;Spain;Korea, Democratic People's Republic of;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan
54NCT02117791
(ClinicalTrials.gov)
July 16, 201416/4/2014Prospective, Non-interventional, Multi-center Post-authorization Safety Study of Riociguat for Chronic Thromboembolic Pulmonary Hypertension (CTEPH )Drug Use Investigation of Riociguat for ChronicThromboembolic Pulmonary Hypertension (CTEPH)Hypertension, PulmonaryDrug: Riociguat (ADEMPAS, BAY63-2521)BayerNULLRecruitingN/AN/AAll1298Japan
55EUCTR2013-003457-25-AT
(EUCTR)
03/07/201406/05/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2013-003457-25-CZ
(EUCTR)
13/06/201401/04/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 20.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China
57EUCTR2013-003457-25-HU
(EUCTR)
11/06/201429/04/2014Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 20.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China
58EUCTR2013-002950-56-NL
(EUCTR)
05/06/201424/02/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 18.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Germany;Netherlands;China;Korea, Republic of
59NCT02094001
(ClinicalTrials.gov)
May 201417/3/2014Pilot Study to Evaluate Right Ventricular Function With Riociguat in CTEPHEvaluation of Right Ventricular Function and Metabolism Following Riociguat for the Treatment of Chronic Thromboembolic Pulmonary Hypertension- Images of RioChronic Thromboembolic Pulmonary HypertensionRadiation: Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)Ottawa Heart Institute Research CorporationBayerCompleted18 YearsN/AAll6Phase 2Canada
60EUCTR2013-003457-25-FR
(EUCTR)
17/04/201420/11/2020Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) - MERIT-2: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension(OL) Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 21.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
78Phase 2United States;Czechia;Thailand;Ukraine;Lithuania;Austria;Chile;Russian Federation;United Kingdom;Switzerland;France;Czech Republic;Hungary;Mexico;Canada;Belgium;Poland;South Africa;Germany;Netherlands;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2012-001646-18-IT
(EUCTR)
08/04/201426/06/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 16.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
62EUCTR2013-002950-56-GB
(EUCTR)
01/04/201429/01/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 16.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Chile;Russian Federation;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China;Sweden
63EUCTR2013-002950-56-DE
(EUCTR)
21/03/201423/01/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 18.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of
64EUCTR2013-002950-56-HU
(EUCTR)
13/03/201420/02/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit®
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of
65EUCTR2013-002950-56-BE
(EUCTR)
27/02/201427/01/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2013-002950-56-CZ
(EUCTR)
20/02/201414/01/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 17.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Bulgaria;Netherlands;Germany;China;Sweden
67EUCTR2013-002950-56-AT
(EUCTR)
12/02/201427/01/2014Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension - MERIT-1: Macitentan in thE tReatment of Inoperable chronic Thromboembolic pulmonary hypertension Inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 19.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Opsumit
Product Name: macitentan
Product Code: ACT-064992
INN or Proposed INN: MACITENTAN
Actelion Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
78Phase 2United States;Thailand;Ukraine;Lithuania;Austria;Russian Federation;Chile;Switzerland;United Kingdom;Vietnam;France;Hungary;Czech Republic;Mexico;Canada;Poland;Belgium;South Africa;Netherlands;Germany;China;Korea, Republic of
68NCT01894022
(ClinicalTrials.gov)
January 23, 20143/7/2013A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An Open-label Extension Study of the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)HypertensionDrug: Ambrisentan 5 mgGlaxoSmithKlineNULLTerminated18 Years80 YearsAll19Phase 3United States;Argentina;Austria;Canada;China;Czechia;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom;Czech Republic
69EUCTR2012-001642-17-NL
(EUCTR)
16/12/201315/08/2013An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 16.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of
70EUCTR2012-002104-40-AT
(EUCTR)
01/10/201311/03/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 17.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bPortugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2012-001646-18-NL
(EUCTR)
27/09/201315/08/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of
72EUCTR2012-001646-18-CZ
(EUCTR)
18/09/201309/07/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
73EUCTR2012-001642-17-CZ
(EUCTR)
18/09/201301/08/2013An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Phase 3Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
74EUCTR2012-001646-18-GB
(EUCTR)
02/09/201312/06/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
75EUCTR2012-001642-17-GB
(EUCTR)
02/09/201312/06/2013An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
GlaxoSmithKline Research & Developement LtdNULLNot Recruiting Female: yes
Male: yes
160Phase 3Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT01884675
(ClinicalTrials.gov)
September 201320/6/2013Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.A Randomised, Multicentre, Double-Blind, Placebo-Controlled Study Of Ambrisentan In Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH).HypertensionDrug: Ambrisentan 5 mg;Drug: PlaceboGlaxoSmithKlineNULLTerminated18 Years80 YearsAll33Phase 3United States;Argentina;Austria;Canada;China;Czech Republic;Germany;Israel;Japan;Korea, Republic of;Mexico;Netherlands;Russian Federation;Saudi Arabia;Spain;United Kingdom
77NCT01953965
(ClinicalTrials.gov)
September 201326/9/2013Look at Way the Heart Functions in People With Pulmonary Hypertension (PH) Who Have Near Normal Right Ventricle (RV) Function and People With Pulmonary Hypertension Who Have Impaired RV Function. Using Imaging Studies PET Scan and Cardiac MRI.11C-acetate/18Fluorodeoxyglucose-FDG PET/Cardiac MRI in Pulmonary HypertensionPulmonary Arterial Hypertension;Chronic Thromboembolic Pulmonary HypertensionDrug: 11C-acetate;Drug: [18F]Fluoro-2-deoxy-2-D-glucose;Drug: MultiHanceBrigham and Women's HospitalUniversity of Pennsylvania;University of Maryland;Yale UniversityTerminated18 Years72 YearsBoth4Phase 2United States
78EUCTR2012-001642-17-DE
(EUCTR)
30/07/201305/06/2013An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 17.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160United States;Saudi Arabia;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan
79EUCTR2012-001646-18-DE
(EUCTR)
30/07/201305/06/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 17.0;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
80EUCTR2012-001642-17-AT
(EUCTR)
19/07/201304/06/2013An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Germany;Netherlands;China;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2012-002104-40-NL
(EUCTR)
18/07/201321/02/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 17.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bPortugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Sweden
82EUCTR2012-001646-18-AT
(EUCTR)
11/07/201304/06/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline Research & Developement LtdNULLNot RecruitingFemale: yes
Male: yes
160Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;China;Japan;Korea, Republic of
83EUCTR2012-002104-40-GB
(EUCTR)
20/05/201319/03/2013 To assess safety and tolerability, clinical effects of riociguat. To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 18.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
500Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;Italy;United Kingdom;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
84JPRN-JapicCTI-132159
01/5/201313/06/2013NS-304 CTEPH OEThe open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) Chronic thromboembolic pulmonary hypertension (CTEPH)Intervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
NIPPON SHINYAKU CO., LTD.NULLBOTH2Phase 2NULL
85NCT01884012
(ClinicalTrials.gov)
May 201313/5/2013Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionPulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionProcedure: long term oxygen therapyUniversity of ZurichNULLCompleted16 Years85 YearsAll30Phase 3Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2012-001642-17-ES
(EUCTR)
26/04/201306/03/2013An extension study of a drug to treat Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An open-label extension study of the long-term safety, tolerability and efficacy of ambrisentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
MedDRA version: 15.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: AMBRISENTAN
Other descriptive name: ambrisentan
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
275United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
87EUCTR2012-001646-18-ES
(EUCTR)
25/04/201309/04/2013Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled studyof ambrisentan in subjects with inoperable chronic thromboembolicpulmonary hypertension (CTEPH) Subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
MedDRA version: 14.1;Level: LLT;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Trade Name: Volibris
Product Name: GSK1325760
Product Code: GSK1325760
INN or Proposed INN: Ambrisentan
Other descriptive name: ambrisentan
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
275United States;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Netherlands;Germany;Japan;China;Korea, Republic of;Sweden
88EUCTR2012-002104-40-CZ
(EUCTR)
18/04/201306/02/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 17.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
89EUCTR2012-002104-40-PT
(EUCTR)
05/04/201317/01/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 19.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
90EUCTR2012-002104-40-ES
(EUCTR)
02/04/201304/02/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 14.1;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bPortugal;United States;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2012-002104-40-BE
(EUCTR)
25/03/201306/02/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 18.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
92EUCTR2012-002104-40-IT
(EUCTR)
21/03/201322/02/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 14.1;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bPortugal;United States;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
93EUCTR2012-002104-40-SE
(EUCTR)
14/03/201317/12/2012To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 18.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden;Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Colombia
94EUCTR2012-002104-40-DK
(EUCTR)
01/03/201320/02/2013To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 14.1;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3bUnited States;Portugal;Spain;Turkey;Austria;Russian Federation;Israel;Colombia;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Sweden;Korea, Republic of
95EUCTR2012-002104-40-DE
(EUCTR)
25/02/201319/12/2012To assess safety and tolerability, clinical effects of riociguat.To provide access to riociguat for patients with in-operable chronic thromboembolic pulmonary hypertension (CTEPH), or recurrent or persisting pulmonary hypertension (PH) after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial.An open-label phase IIIb study of riociguat in patients with in-operable CTEPH, or recurrent or persisting PH after surgical treatment who are not satisfactorily treated and cannot participate in any other CTEPH trial - Phase IIIb study of riociguat in patients with chronic thromboembolic pulmonary hypertension Chronic Trombo Embolic Pulmonary Hypertention
MedDRA version: 19.0;Level: LLT;Classification code 10068740;Term: CTEPH;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521 IR tablet 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 IR tablet 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Mexico;Canada;Belgium;Brazil;Denmark;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT01784562
(ClinicalTrials.gov)
January 20134/2/2013Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)An Open-label Phase IIIb Study of Riociguat in Patients With In-operable CTEPH, or Recurrent or Persisting PH After Surgical Treatment Who Are Not Satisfactorily Treated and Cannot Participate in Any Other CTEPH TrialHypertension, PulmonaryDrug: Adempas (Riociguat, BAY63-2521)BayerNULLNo longer available18 Years80 YearsBothPhase 3bUnited States;Austria;Belgium;Canada;Colombia;Czech Republic;Denmark;France;Germany;Italy;Japan;Mexico;Netherlands;Portugal;Russian Federation;Spain;Sweden;Switzerland;Turkey;United Kingdom
97NCT01748474
(ClinicalTrials.gov)
December 20124/10/2012Effect of Short-term Oxygen During CPET in Pulmonary HypertensionEffect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary HypertensionPulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension;Chronic Cardiorespiratory DiseaseProcedure: Supplemental oxygen via a maskUniversity of ZurichNULLCompleted20 Years80 YearsBoth20Phase 2Switzerland
98JPRN-JapicCTI-111666
01/6/201018/10/2011NS-304 CTEPH OL studyThe open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who completed the exploratory evaluation study Chronic thromboembolic pulmonary hypertension (CTEPH)Intervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd.NULLBOTH32Phase 2NULL
99EUCTR2008-006441-10-DE
(EUCTR)
27/05/201028/01/2010Double Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary HypertensionDouble Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary HypertensionTrade Name: Remodulin 1mg/ml 20ml
Other descriptive name: TREPROSTINIL SODIUM
Trade Name: Remodulin 2.5mg/ml 20ml
Other descriptive name: TREPROSTINIL SODIUM
Trade Name: Remodulin 5mg/ml 20ml
Other descriptive name: TREPROSTINIL SODIUM
Trade Name: Remodulin 10mg/ml 20ml
Other descriptive name: TREPROSTINIL SODIUM
MRN-Medical Research Network GmbHNULLNot RecruitingFemale: yes
Male: yes
100Czech Republic;Germany;Austria
100JPRN-JapicCTI-111667
01/2/201018/10/2011NS-304 CTEPH DB studyAn exploratory study to assess the efficacy and safety of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) Chronic thromboembolic pulmonary hypertension (CTEPH)Intervention name : NS-304
INN of the intervention : Selexipag
Dosage And administration of the intervention : Oral administration
Control intervention name : Placebo
Dosage And administration of the control intervention : Oral administration
NIPPON SHINYAKU CO., LTD. / Actelion Pharmaceuticals Japan Ltd.NULL2075BOTH32Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2007-000072-16-DK
(EUCTR)
15/01/201004/11/2009Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
102EUCTR2008-003539-19-DK
(EUCTR)
15/01/201004/11/2009Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
INN or Proposed INN: riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
103EUCTR2008-003539-19-SK
(EUCTR)
14/01/201014/01/2010Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 19.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
104EUCTR2007-000072-16-SK
(EUCTR)
23/11/200910/09/2009Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary HypertensionBayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
105EUCTR2008-003539-19-PT
(EUCTR)
03/11/200921/09/2009Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 19.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
270Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2007-000072-16-PT
(EUCTR)
26/10/200921/09/2009Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary HypertensionProduct Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
107EUCTR2008-006441-10-CZ
(EUCTR)
15/10/200924/07/2009Study to evaluate the efficacy and safety of Treprostinil which will becontinuously administered under the skin by patients with inoperableChronic Thromboembolic Pulmonary Hypertension.A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH II) Patients with Severe inoperable Chronic Thromboembolic Pulmonary Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: Treprostinil Sodium
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM
Product Name: Treprostinil Sodium
INN or Proposed INN: Treprostinil
Other descriptive name: TREPROSTINIL SODIUM
SCIPHARM SáRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Czech Republic;Slovakia;Poland;Austria;Germany
108EUCTR2008-006441-10-SK
(EUCTR)
31/08/200909/09/2009Double Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary HypertensionDouble Blind Controlled Clinical Investigation into the Efficacy and Tolerability of subcutaneously administered Treprostinil Sodium in Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary HypertensionTrade Name: Remodulin (R)
Trade Name: Remodulin (R)
MRN-Medical Research Network GmbHNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Czech Republic;Slovakia;Austria;Germany
109NCT00910429
(ClinicalTrials.gov)
July 1, 200927/5/2009BAY63-2521 - Long-term Extension Study in Patients With Chronic Thromboembolic Pulmonary HypertensionLong-term Extension, Multicentre, Multi-international Study to Evaluate the Safety and Tolerability of Oral BAY63-2521 (1mg, 1.5 mg, 2.0 mg, 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).Pulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521)BayerNULLCompleted18 Years80 YearsAll237Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;United Kingdom;Czech Republic;Ireland;Netherlands
110EUCTR2008-006441-10-AT
(EUCTR)
03/06/200909/12/2008 Study to evaluate the efficacy and safety of Treprostinil which will be continuously administered under the skin by patients with inoperable Chronic Thromboembolic Pulmonary Hypertension. A double blind controlled clinical study to investigate the efficacy and tolerability of subcutaneous Treprostinil sodium in patients with severe non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH II) Patients with Severe (inoperable) Chronic Thromboembolic Pulmonary Hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]SCIPHARM SáRLNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100Phase 3Czech Republic;Slovakia;Poland;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2008-003539-19-CZ
(EUCTR)
22/05/200906/05/2009Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
112EUCTR2008-003539-19-GB
(EUCTR)
20/04/200925/11/2010Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertention
MedDRA version: 20.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Bayer AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
113EUCTR2007-000072-16-CZ
(EUCTR)
09/04/200927/03/2009Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary Hypertension Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Czech Republic;United Kingdom;Slovakia;Belgium;Denmark;Spain
114EUCTR2008-003539-19-IE
(EUCTR)
06/04/200908/01/2009Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertention
MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AG, Bayer Vital GmbH, D-51368 LeverkusenNULLNot RecruitingFemale: yes
Male: yes
270Portugal;United Kingdom;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Ireland;Italy;Austria
115EUCTR2007-000072-16-AT
(EUCTR)
13/03/200921/10/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary HypertensionProduct Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2008-003539-19-AT
(EUCTR)
13/03/200918/11/2008Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 17.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Trade Name: Adempas
Product Name: BAY 63-2521 coated tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
117EUCTR2007-000072-16-GB
(EUCTR)
09/03/200917/10/2008Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 14.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Bayer HealthCare AG, D-51368 LeverkusenNULLNot Recruiting Female: yes
Male: yes
270Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Brazil;Germany;Japan
118EUCTR2008-003539-19-BE
(EUCTR)
05/03/200923/01/2009Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 18.0;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;United States;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
119NCT01416636
(ClinicalTrials.gov)
March 200912/8/2011Efficacy and Tolerability of Subcutaneously Administered Treprostinil Sodium in Patients With Severe (Non-operable) Chronic Thromboembolic Pulmonary Hypertension (CTREPH)A Double Blind Controlled Clinical Study to Investigate the Efficacy and Tolerability of Subcutaneous Treprostinil Sodium in Patients With Severe Non-operable Chronic Thromboembolic Pulmonary Hypertension (CTREPH)Non-operable Chronic Thromboembolic Pulmonary HypertensionDrug: Treprostinil sodiumSciPharm SàRLNULLActive, not recruiting18 Years100 YearsAll105Phase 3Austria;Czechia;Germany;Poland;Czech Republic
120EUCTR2007-000072-16-NL
(EUCTR)
13/02/200930/10/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary Hypertension Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;United Kingdom;Czech Republic;Slovakia;Belgium;Denmark;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2008-003539-19-NL
(EUCTR)
13/02/200930/10/2008Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertention
MedDRA version: 13.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Bayer HealthCare AG, Bayer Vital GmbH, D-51368 LeverkusenNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Netherlands;Germany
122NCT00855465
(ClinicalTrials.gov)
February 200915/12/2008A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With CTEPH.Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national Study to Evaluate the Efficacy and Safety of Oral BAY63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg Tid) in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Pulmonary HypertensionDrug: Riociguat (Adempas, BAY63-2521);Drug: PlaceboBayerNULLCompleted18 Years80 YearsAll262Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Czech Republic;Denmark;France;Germany;Ireland;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Switzerland;Taiwan;Turkey;United Kingdom
123EUCTR2008-003539-19-FR
(EUCTR)
14/01/200913/11/2008Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertention
MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary
Bayer HealthCare AG, Bayer Vital GmbH, D-51368 LeverkusenNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
124EUCTR2007-000072-16-IE
(EUCTR)
13/01/200910/10/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary HypertensionProduct Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
125EUCTR2007-000072-16-BE
(EUCTR)
07/01/200921/11/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary HypertensionBayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2007-000072-16-FR
(EUCTR)
27/12/200814/11/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary HypertensionProduct Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
127EUCTR2007-000072-16-ES
(EUCTR)
26/12/200827/10/2008 Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Ensayo clínico, multinacional, multicéntrico, aleatorizado ,doble ciego, controlado con placebo, para evaluar la eficacia y la seguridad de BAY 63-2521 (1 mg, 1.5 mg, 2mg, o 2.5 mg,tid), administrado por vía oral, en pacientes con Hipertensión Pulmonar Tromboembólica Crónica (HPTEC). Estudio CHEST ?1 Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Hipertensión Pulmonar Tromboembólica Crónica (HPTEC) Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
128EUCTR2007-000072-16-IT
(EUCTR)
15/12/200820/11/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST 1Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST 1 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 9.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270Phase 3Portugal;Slovakia;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
129EUCTR2008-003539-19-DE
(EUCTR)
26/11/200820/10/2008Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 in different dosesLong-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-2 Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 14.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 100000004855
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Bayer HealthCare AG,NULLNot RecruitingFemale: yes
Male: yes
270Phase 3United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Germany;Japan
130ChiCTR-TNRC-08000263
2008-06-012008-12-18The study of the intervention with statin on PE and CTEPHThe study of the intervention with statin on PE and CTEPH pulmonary embolism and chronic thromboembolic pulmonary hypertensionGroup A:basic treatment + atorvastatin;Group B:basic treatment;Tongji Hospital of Tongji UniversityNULLCompleted1880BothGroup A:30;Group B:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2006-003520-10-DE
(EUCTR)
20/10/200623/08/2006Long-term study to collect additional information to evaluate the saftey and tolerability of BAY 63-2521 in different dosesA multicenter, non-randomized, non-blinded, non-controlled study to investigate the impact of multiple doses of BAY 63 2521 on safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with pulmonary hypertension in a 12 week 3 times a day individual dose titration scheme Subjects with PH due to• Pulmonary arterial hypertension (PAH) [Venice protocol] or• Chronic thrombembolic PH (CTEPH)
MedDRA version: 19.0;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Product Name: BAY 63-2521
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
0Phase 1;Phase 2Germany
132EUCTR2005-002900-40-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)Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
128Phase 3Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom
133EUCTR2005-002900-40-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
134EUCTR2005-002900-40-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
135EUCTR2005-002900-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2005-002900-40-BE
(EUCTR)
18/01/200609/01/2006BENEFIT-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)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.NULLNot RecruitingFemale: yes
Male: yes
128Czech Republic;Spain;Belgium;Austria;Germany;Italy;United Kingdom
137NCT00319111
(ClinicalTrials.gov)
January 200626/4/2006Bosentan 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 HypertensionDrug: bosentanActelionNULLCompleted18 Years80 YearsAll151Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
138EUCTR2005-001965-33-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
139EUCTR2005-001965-33-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
140EUCTR2005-001965-33-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)Actelion Pharmaceuticals Ltd.NULLNot Recruiting Female: yes
Male: yes
128Phase 3Czech Republic;Spain;Austria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2005-001965-33-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
142EUCTR2005-001965-33-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
143NCT00313222
(ClinicalTrials.gov)
October 200510/4/2006Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary HypertensionProspective, 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 HypertensionDrug: bosentanActelionNULLCompleted18 Years80 YearsBoth157Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
144EUCTR2005-002900-40-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
145EUCTR2007-000072-16-DE
(EUCTR)
29/09/2008Randomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 StudyRandomized, double-blind, placebo-controlled, multi-centre, multi-national study to evaluate the efficacy and safety of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). - CHEST-1 Study Chronic Thromboembolic Pulmonary Hypertension
MedDRA version: 14.1;Level: LLT;Classification code 10037406;Term: Pulmonary hypertension secondary;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
INN or Proposed INN: riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
270Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands