BAY 63-2521 Tablet ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
86Pulmonary arterial hypertension24

86. Pulmonary arterial hypertension


Clinical trials : 1,181 Drugs : 701 - (DrugBank : 126) / Drug target genes : 105 - Drug target pathways : 192
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2013-001759-10-CZ
(EUCTR)
23/01/201424/10/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
2EUCTR2013-001759-10-IT
(EUCTR)
14/01/201428/10/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland;Italy
3EUCTR2013-001759-10-FR
(EUCTR)
06/01/201428/09/2015Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with approved dosages of phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;France;Czech Republic;Canada;Belgium;Germany;United Kingdom;Italy;Switzerland
4EUCTR2013-001759-10-DE
(EUCTR)
03/01/201415/10/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)Open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
5EUCTR2013-001759-10-BE
(EUCTR)
20/12/201320/11/2013Open-label, international, multicenter, non-placebo controlled (uncontrolled), phase IIIb study of riociguat in patients with Pulmonary Arterial Hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i)An open-label, international, multicenter, single-arm, uncontrolled, phase IIIb study of riociguat in patients with pulmonary arterial hypertension (PAH) who demonstrate an insufficient response to treatment with phosphodiesterase-5 inhibitors (PDE-5i) - RESPITE Hypertension, Pulmonary;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: BAY 63-2521 Tablet
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
70Phase 2;Phase 3United States;Czech Republic;Canada;Belgium;Germany;United Kingdom;Switzerland
6EUCTR2008-003610-94-GR
(EUCTR)
15/06/201011/01/2010Long-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-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
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;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
7EUCTR2008-003482-68-GR
(EUCTR)
15/06/201009/11/2009Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study, amend 4 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
462Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
8EUCTR2008-003482-68-PT
(EUCTR)
04/11/200922/09/2009Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 14.0;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;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
462United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Germany;Japan;New Zealand;Sweden
9EUCTR2008-003610-94-ES
(EUCTR)
29/09/200929/07/2009Estudio de extensión a largo plazo, multicéntrico y multinacional, para evaluar la seguridad y tolerabilidad de BAY 63 2521 (1 mg, 1,5 mg, 2 mg o 2,5 mg tid) administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática. Estudio PATENT-2 - PATENT-2Estudio de extensión a largo plazo, multicéntrico y multinacional, para evaluar la seguridad y tolerabilidad de BAY 63 2521 (1 mg, 1,5 mg, 2 mg o 2,5 mg tid) administrado por vía oral, en pacientes con Hipertensión Arterial Pulmonar (HAP) sintomática. Estudio PATENT-2 - PATENT-2 Hipertensión Arterial Pulmonar Sintomática
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
10EUCTR2008-003482-68-ES
(EUCTR)
08/06/200924/10/2008 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 Arterial Pulmonar (HAP) sintomática-Estudio PATENT -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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 Arterial Pulmonar (HAP) sintomática-Estudio PATENT -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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Hipertensión Arterial Pulmonar (HAP) Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
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;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
11EUCTR2008-003610-94-IE
(EUCTR)
06/04/200909/01/2009Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 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 AGNULLNot RecruitingFemale: yes
Male: yes
462Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
12EUCTR2008-003482-68-DK
(EUCTR)
16/03/200902/02/2009Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 AG, D-51368 LeverkusenNULLNot RecruitingFemale: yes
Male: yes
462Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
13EUCTR2008-003482-68-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
462Phase 3Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
14EUCTR2008-003482-68-GB
(EUCTR)
09/03/200907/01/2009Study to evaluate the efficacy and safety of different doses of Bay 63-2521 in patients with pulmonary arterial hypertension.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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 14.0;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]
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 AG, D-51368 LeverkusenNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Portugal;United States;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;Switzerland;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Singapore;Germany;New Zealand;Japan;Sweden
15EUCTR2008-003482-68-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
462Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
16EUCTR2008-003610-94-NL
(EUCTR)
13/02/200928/04/2009Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 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
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;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Netherlands;Germany;Sweden
17EUCTR2008-003482-68-CZ
(EUCTR)
23/01/200923/01/2009Study to assess the efficacy and safety of different doses of a new drug (BAY 63 2521), given orally to patients with Pulmonary Arterial Hypertension.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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 14.0;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]
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
462Germany;France;Ireland;Singapore;Austria;Sweden;Brazil;Australia;Czech Republic;Canada;New Zealand;Belgium;Korea, Republic of;United States;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Israel;United Kingdom;Russian Federation;Taiwan;Denmark;Argentina;Mexico;China;Thailand;Spain;Japan
18EUCTR2008-003482-68-BE
(EUCTR)
14/01/200913/02/2009Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 AG, D-51368 LeverkusenNULLNot RecruitingFemale: yes
Male: yes
462Phase 3Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
19EUCTR2008-003610-94-FR
(EUCTR)
14/01/200907/11/2008Long-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-2 Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 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
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;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
20EUCTR2008-003482-68-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
462Phase 3Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
21EUCTR2008-003482-68-FR
(EUCTR)
27/12/200806/11/2008Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
462Phase 3Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
22EUCTR2008-003482-68-SE
(EUCTR)
05/12/200807/11/2008Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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 AG, D-51368 LeverkusenNULLNot RecruitingFemale: yes
Male: yes
462Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden
23EUCTR2008-003610-94-DE
(EUCTR)
26/11/200831/10/2008Long-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: 15.1;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]
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 AGNULLNot RecruitingFemale: yes
Male: yes
462Phase 3United States;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Netherlands;China;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Japan;New Zealand;Sweden
24EUCTR2008-003482-68-DE
(EUCTR)
26/11/200802/10/2008Randomized, 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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-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 symptomatic Pulmonary Arterial Hypertension (PAH). - PATENT-1 Study Pulmonary Arterial Hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial 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
462Portugal;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Sweden