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 88. 慢性血栓塞栓性肺高血圧症 [臨床試験数:49,薬物数:54(DrugBank:23),標的遺伝子数:10,標的パスウェイ数:6] 

Searched query = "Chronic thromboembolic pulmonary hypertension", "CTEPH", "Idiopathic chronic pulmonary thromboembolism"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04081012May 21, 201930 September 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 ChavezRecruitingN/AN/AAll34N/AMexico
2NCT03806907April 1, 201925 February 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 recruiting18 Years90 YearsAll100Phase 3
3NCT03754660January 21, 201911 November 2019This 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 gasBayerRecruiting18 Years80 YearsAll60Phase 1Germany
4NCT03689244January 14, 201916 September 2019A 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 SurgeryA 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: Placebo;Drug: SelexipagActelionRecruiting18 Years85 YearsAll400Phase 3United States;Argentina;Belgium;Brazil;Bulgaria;Czechia;Hungary;Israel;Korea, Republic of;Mexico;Netherlands;Poland;Portugal;Russian Federation;Sweden;Taiwan;Thailand;Turkey;United Kingdom
5NCT03809650January 8, 20194 November 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 CorporationRecruiting18 Years89 YearsAll27Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03273257August 17, 201824 September 2018Riociguat 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 AssociationRecruiting18 Years80 YearsAll80Phase 2United States;France;Germany;United Kingdom
7EUCTR2017-001121-40-DE17/05/201823 July 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 endarterectomyChronic 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
Pharmaceutical Form: Tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
Pharmaceutical Form: Tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
Pharmaceutical Form: Tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
Pharmaceutical Form: Tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Adempas®
Product Name: Riociguat
Product Code: BAY 63-2521
Pharmaceutical Form: Tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
International CTEPH Association (ICA)AuthorisedFemale: yes
Male: yes
88Phase 2France;United States;Germany;United Kingdom
8NCT03074539February 1, 201718 March 2019Sleep-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 ViennaRecruiting18 YearsN/AAll50N/AAustria
9EUCTR2016-000347-14-ES16/06/201620 June 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 subjectsPulmonary 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 Level: LLT 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
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLUDEOXYGLUCOSE
CAS Number: 105851-17-0
Other descriptive name: FLUDEOXYGLUCOSE
Concentration unit: MBq megabecquerel(s)
Concentration type: up to
Concentration number: 3000-
IDIBAPSAuthorisedFemale: yes
Male: yes
Phase 2Spain
10JPRN-JapicCTI-16327910/6/201616 July 2019A 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.Not Recruiting2085BOTH72Phase 3Japan
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11JPRN-jRCTs03118023914/04/201622 July 2019MR BPA studyMulticenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertension - MR BPA studyChronic 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.
Keiichi FukudaTakashi KawakamiRecruiting>=20 age old<=80 age oldBoth60N/Anone
12JPRN-UMIN0000195492016/04/012 April 2019Multicenter Randomized controlled trial based on Balloon Pulmonary Angioplasty for chronic thromboembolic pulmonary hypertensionChronic 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 MedicineRecruiting20years-old80years-oldMale and Female60Not selectedJapan
13JPRN-UMIN0000185202016/01/012 April 2019Clinical efficacy and safety of edoxaban for treatment of chronic thromboembolic pulmonary hypertensionCTEPH (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 MedicineNot Recruiting20years-oldNot applicableMale and Female60Phase 4Japan
14NCT02634203January 201616 December 2017Riociguat 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
15NCT02545465September 15, 201516 December 2017A 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)BayerNot recruitingN/AN/AAll125N/ABelgium;Canada;Colombia;Germany;Japan;Sweden;Turkey;Denmark;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT02558582September 201526 August 2019Effect 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 ZurichRecruiting18 YearsN/AAll32N/ASwitzerland
17JPRN-UMIN0000268822015/04/015 November 2019Effect 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 CenterRecruiting20years-oldNot applicableMale and Female100Not applicableJapan
18NCT03195543March 12, 20151 April 2019Assessment 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 AthensRecruiting18 YearsN/AAll60N/AGreece
19EUCTR2013-003457-25-GB22/09/201428 February 2019Long-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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Actelion Pharmaceuticals Ltd.Authorised Female: yes
Male: yes
78Phase 2China;Germany;Netherlands;South Africa;Belgium;Poland;Canada;Mexico;Czech Republic;Hungary;France;Switzerland;United Kingdom;Chile;Russian Federation;Austria;Lithuania;Ukraine;Thailand;United States
20NCT02021292August 20, 20145 March 2018Clinical 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: PlaceboActelionNot recruiting18 Years84 YearsAll80Phase 2Canada;Chile;Czech Republic;Italy;Netherlands;South Africa;United States;Vietnam;Bulgaria;Belgium;China;Czechia;France;Germany;Hungary;Korea, Republic of;Lithuania;Mexico;Poland;Russian Federation;Switzerland;Thailand;Turkey;Ukraine;United Kingdom;Austria
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2013-003457-25-DE14/08/201428 February 2019Long-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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Actelion Pharmaceuticals Ltd.Authorised Female: 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
22NCT02117791July 16, 20144 November 2019Prospective, 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)BayerNot recruitingN/AN/AAll1298Phase 3Japan
23EUCTR2013-003457-25-CZ13/06/201420 August 2018Long-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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Actelion Pharmaceuticals Ltd.Not 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
24NCT02094001May 201410 September 2018Pilot 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 CorporationBayerNot recruiting18 YearsN/AAll6Phase 2Canada
25EUCTR2013-002950-56-DE21/03/20142 October 2017Study 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 hypertensionInoperable 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Actelion Pharmaceuticals Ltd.Not RecruitingFemale: yes
Male: yes
78Phase 2Korea, Republic of;China;Germany;Netherlands;South Africa;Belgium;Poland;Canada;Mexico;Czech Republic;Hungary;France;Vietnam;United Kingdom;Switzerland;Chile;Russian Federation;Austria;Lithuania;Ukraine;Thailand;United States
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2013-002950-56-CZ20/02/20142 October 2017Study 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 hypertensionInoperable 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: MACITENTAN
CAS Number: 441798-33-0
Current Sponsor code: ACT-064992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Actelion Pharmaceuticals Ltd.Not 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
27NCT01894022January 23, 201416 December 2017A 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 mgGlaxoSmithKlineNot recruiting18 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
28NCT01884675September 201316 December 2017Ambrisentan 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: PlaceboGlaxoSmithKlineNot recruiting18 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
29NCT01953965September 20138 August 2016Look 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 UniversityNot recruiting18 Years72 YearsBoth4Phase 2United States
30JPRN-JapicCTI-13215901/5/201323 April 2019NS-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.BOTH2Phase 2
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
31NCT01884012May 201316 December 2017Effect 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 ZurichNot recruiting16 Years85 YearsAll30Phase 3Switzerland
32EUCTR2012-001642-17-ES26/04/20137 December 2015An 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AMBRISENTAN
CAS Number: 177036-94-1
Current Sponsor code: GSK1325760
Other descriptive name: ambrisentan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
GlaxoSmithKline, S.A.Not 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
33EUCTR2012-001646-18-ES25/04/201310 July 2015Study of a drug to treat chronic thromboembolic pulmonary hypertension (CTEPH)A randomised, multicentre, double-blind, placebo-controlled study 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ambrisentan
CAS Number: 177036-94-1
Current Sponsor code: GSK1325760
Other descriptive name: ambrisentan
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
GlaxoSmithKline, S.A.Not 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
34EUCTR2012-002104-40-SE14/03/201329 August 2016To 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 hypertensionChronic 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Product Name: BAY 63-2521 IR tablet 1.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Product Name: BAY 63-2521 IR tablet 2.0 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Product Name: BAY 63-2521 IR tablet 2.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: RIOCIGUAT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Bayer HealthCare AGNot 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
35NCT01748474December 201222 August 2016Effect 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 ZurichNot recruiting20 Years80 YearsBoth20Phase 2Switzerland
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36JPRN-JapicCTI-11166601/6/201023 April 2019NS-304 CTEPH OL studyThe open-label extension study of NS-304 in patients with chronic thromboembolic pulmonary hypertension (CTEPH) who completed the exploratory evaluation studyChronic 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.BOTH32Phase 2
37JPRN-JapicCTI-11166701/2/201023 April 2019NS-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.2075BOTH32Phase 2
38NCT00910429July 1, 20099 September 2019BAY63-2521 - 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)BayerNot recruiting18 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
39EUCTR2008-006441-10-AT03/06/200928 February 2019Study 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]Product Name: Treprostinil Sodium
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Treprostinil
CAS Number: 289480644
Other descriptive name: TREPROSTINIL SODIUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
INN or Proposed INN: Treprostinil
CAS Number: 289480644
Other descriptive name: TREPROSTINIL SODIUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2,5-
INN or Proposed INN: Treprostinil
CAS Number: 289480644
Other descriptive name: TREPROSTINIL SODIUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
INN or Proposed INN: Treprostinil
CAS Number: 289480644
Other descriptive name: TREPROSTINIL SODIUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Product Name: Treprostinil Sodium
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Treprostinil
CAS Number: 289480644
Other descriptive name: TREPROSTINIL SODIUM
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
SCIPHARM SáRLAuthorised Female: yes
Male: yes
100Phase 3Czech Republic;Slovakia;Poland;Austria;Germany
40NCT01416636March 200916 December 2017Efficacy 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 SàRLNot recruiting18 Years100 YearsAll100Phase 3Austria;Czechia;Germany;Poland;Czech Republic
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2008-003539-19-NL13/02/200926 September 2016Long-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-2Chronic 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
Product Name: BAY 63-2521 tablets 0.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Product Name: BAY 63-2521 tablets 2.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Bayer HealthCare AG, Bayer Vital GmbH, D-51368 LeverkusenNot RecruitingFemale: yes
Male: yes
270Phase 3Portugal;France;Czech Republic;Belgium;Spain;Ireland;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy
42EUCTR2008-003539-19-DE26/11/200825 February 2013Long-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-2Chronic 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Product Name: BAY 63-2521 tablets 2.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Bayer HealthCare AG,AuthorisedFemale: yes
Male: yes
270United States;Portugal;Taiwan;Slovakia;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;Japan
43ChiCTR-TNRC-080002632008-06-0118 April 2017The study of the intervention with statin on PE and CTEPHThe study of the intervention with statin on PE and CTEPHpulmonary embolism and chronic thromboembolic pulmonary hypertensionGroup A:basic treatment + atorvastatin;Group B:basic treatment;Tongji Hospital of Tongji UniversityNot Recruiting1880BothGroup A:30;Group B:30;Post-marketChina
44EUCTR2007-000072-16-DE7 January 2013Randomized, 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 StudyChronic 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAY 63-2521 tablets 1 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAY 63-2521 tablets 1.5 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Product Name: BAY 63-2521 tablets 2 mg
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo [3,4-b]pyridine-3-yl]-5-pyrimidinyl(methyl)carb
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Bayer HealthCare AGNot RecruitingFemale: yes
Male: yes
270Portugal;Slovakia;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands
45EUCTR2006-003520-10-DE20/10/200628 November 2016Long-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 schemeSubjects 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.5-
Product Name: BAY 63-2521
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Product Name: BAY 63-2521
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.0-
Product Name: BAY 63-2521
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.5-
Product Name: BAY 63-2521
Product Code: BAY 63-2521
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riociguat
CAS Number: 625115-55-1
Current Sponsor code: BAY 63-2521
Other descriptive name: Methyl [4,6-diamino-2-[1-[(2-fluorophenyl)methyl]-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-pyrimidinyl]meth
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.0-
Bayer HealthCare AGNot RecruitingFemale: yes
Male: yes
0Phase 1;Phase 2Germany
No.TrialIDDate_
enrollement
Last_Refreshed_
on
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT00319111January 200619 October 2017Bosentan 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: bosentanActelionNot recruiting18 Years80 YearsAll151Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
47EUCTR2005-001965-33-DE01/11/200518 April 2012Prospective, 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) - BENEFITInoperable 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
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Current Sponsor code: Ro-47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Current Sponsor code: Ro-47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Actelion Pharmaceuticals Ltd.Not RecruitingFemale: yes
Male: yes
128United Kingdom;Germany;Spain;Italy
48NCT00313222October 200519 February 2015Bosentan 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: bosentanActelionNot recruiting18 Years80 YearsBoth157Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom
49EUCTR2005-002900-40-AT15/08/200527 May 2013BENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OLBENEFIT-OL / Long-term open-label extension study in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who completed protocol AC-052-366/BENEFIT - BENEFIT-OLInoperable chronic thromboembolic pulmonary hypertension (CTEPH)Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Current Sponsor code: Ro-47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 62.5-
Trade Name: Tracleer
Product Name: bosentan
Product Code: Ro 47-0203
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: bosentan monohydrate
CAS Number: 157212-55-0
Current Sponsor code: Ro-47-0203/029
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-
Actelion Pharmaceuticals Ltd.Not RecruitingFemale: yes
Male: yes
128Czech Republic;Spain;Austria;Germany;Italy;United Kingdom

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