BAY 63-2521 IR tablets 2.0 mg ( DrugBank: - )


1 disease
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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2010-018863-40-ES
(EUCTR)
29/07/201120/06/2011Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 13.1;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 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Poland;Spain;Austria;Germany;United Kingdom;Italy
2EUCTR2010-018863-40-GB
(EUCTR)
24/06/201124/03/2011Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.1;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 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Spain;Poland;Austria;Germany;Italy;United Kingdom
3EUCTR2010-018863-40-PL
(EUCTR)
25/01/201107/06/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
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 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
4EUCTR2010-018863-40-AT
(EUCTR)
05/01/201120/07/2010An interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUSAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Product Name: BAY 63-2521 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Bayer Health Care AGNULLNot RecruitingFemale: yes
Male: yes
36United Kingdom;Czech Republic;Germany;Spain;Italy;Poland;Austria
5EUCTR2010-018863-40-CZ
(EUCTR)
22/07/201002/06/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.1;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 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
36Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy
6EUCTR2010-018863-40-DE
(EUCTR)
16/07/201026/04/2010Evaluation of the pharmacodynamic effect of the combination of Sildenafil and Riociguat on blood pressure and other safety parametersAn interaction study to evaluate changes in blood pressure following 1, 1.5, 2, and 2.5 mg riociguat tid (dose titration) compared to placebo treatment on the background of stable sildenafil pretreatment in subjects with symptomatic pulmonary arterial hypertension - PATENT PLUS Pulmonary arterial hypertension
MedDRA version: 14.1;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 IR tablets 1.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 2.0 mg
Product Code: BAY 63-2521
INN or Proposed INN: Riociguat
Other descriptive name: Methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazolo
Product Name: BAY 63-2521 IR 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
Product Name: BAY 63-2521 IR tablets 0.5 mg
Product Code: BAY 63-2521
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
18Czech Republic;Spain;Poland;Austria;Germany;United Kingdom;Italy