TRACLEER*125MG 56CPR RIV. ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
51全身性強皮症1
86肺動脈性肺高血圧症1

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-000631-28-IT
(EUCTR)
14/09/200417/09/2004Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2.Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2. Interstitial lung disease associated with systemic sclerosisTrade Name: TRACLEER*125MG 56CPR RIV.
Product Name: NA
Product Code: NA
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
Italy

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-000745-37-IT
(EUCTR)
15/03/200521/06/2005Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension)Uncontrolled extension trial to protocol AC-052-406 to evaluate the long term effect of bosentan therapy in patient with pulmonary arterial hypertension related to connective tissue disease (TRUST-extension) No modification of the label due to the fact that is an open label extension of a phase IV trial.
MedDRA version: 6.1;Level: PT;Classification code 10037406
Trade Name: TRACLEER*125MG 56CPR RIV.
INN or Proposed INN: Bosentan
ACTELION PHARMACEUTICALS ITALIANULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Spain;Italy