BAY 63-2521 coated tablets 2 mg ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
86肺動脈性肺高血圧症7
88慢性血栓塞栓性肺高血圧症6

86. 肺動脈性肺高血圧症


臨床試験数 : 1,181 薬物数 : 701 - (DrugBank : 126) / 標的遺伝子数 : 105 - 標的パスウェイ数 : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-003610-94-PT
(EUCTR)
04/11/200922/09/2009Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 19.0;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: 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
462Phase 3United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Singapore;Poland;Belgium;Brazil;Germany;New Zealand;Japan;Sweden
2EUCTR2008-003610-94-GB
(EUCTR)
20/05/200927/11/2008Long-term study to collect additional information to evaluate the safety and tolerability of BAY 63-2521 at 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 20.0;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: 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: R
Bayer AGNULLNot Recruiting Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;China;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Germany;New Zealand;Japan;Sweden
3EUCTR2008-003610-94-DK
(EUCTR)
24/04/200912/03/2009Long-term study to collect additional information to evaluate the safetyand 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 17.0;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: 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
462Phase 3Portugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden
4EUCTR2008-003610-94-AT
(EUCTR)
13/03/200918/11/2008Long-term study to collect additional information to evaluate the safetyand 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 17.0;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: 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
462Phase 3Portugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden
5EUCTR2008-003610-94-BE
(EUCTR)
05/03/200923/01/2009 Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 18.0;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: 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
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden
6EUCTR2008-003610-94-CZ
(EUCTR)
12/02/200902/02/2009 Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 17.0;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: 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
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden
7EUCTR2008-003610-94-SE
(EUCTR)
08/12/200814/11/2008 Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 18.0;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: 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
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
462 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Greece;Thailand;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;Singapore;Germany;New Zealand;Japan;Sweden

88. 慢性血栓塞栓性肺高血圧症


臨床試験数 : 159 薬物数 : 118 - (DrugBank : 23) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 53
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-003539-19-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
2EUCTR2008-003539-19-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
3EUCTR2008-003539-19-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]
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
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
4EUCTR2008-003539-19-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]
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: r
Bayer AGNULLNot Recruiting Female: yes
Male: yes
270 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
5EUCTR2008-003539-19-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
6EUCTR2008-003539-19-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]
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
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
270 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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