Tadalafil 20 mg film-coated tablets ( DrugBank: Tadalafil )


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3

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
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size
PhaseCountries
1EUCTR2009-011150-17-FR
(EUCTR)
24/09/201013/08/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypertension
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
MedDRA version: 12.1;Level: PT;Term: Pulmonary arterial hypertension
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
352 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
2EUCTR2009-011150-17-GB
(EUCTR)
11/08/201022/06/2010Study of two drugs used to treat pulmonary arterial hypertension (PAH)AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot Recruiting Female: yes
Male: yes
545 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
3EUCTR2009-011150-17-GR
(EUCTR)
16/07/201014/07/2010AMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITIONAMBITION: A Randomised, Multicenter Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects with Pulmonary Arterial Hypertension - AMBITION Pulmonary arterial hypotension
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Volibris
Product Name: ambrisentan 5 mg film-coated tablets
INN or Proposed INN: AMBRISENTAN
Trade Name: Cialis
Product Name: tadalafil 20 mg film-coated tablets
INN or Proposed INN: TADALAFIL
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
352France;Greece;Belgium;Spain;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden