Glivec® ( 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13

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_
sponsor
Secondary_
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Recruitment_
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agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1EUCTR2010-021960-14-DE
(EUCTR)
08/04/201103/03/2011An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertensionAn open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy of QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension Pulmonary arterial hypertension (PAH)
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
20Germany;Italy
2EUCTR2009-018167-26-FR
(EUCTR)
04/11/201013/09/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
3EUCTR2009-018167-26-GB
(EUCTR)
07/09/201021/06/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Austria;Germany;Italy;United Kingdom
4EUCTR2009-018167-26-BE
(EUCTR)
31/08/201018/05/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 3France;Spain;Belgium;Austria;Germany;Italy;United Kingdom
5EUCTR2009-018167-26-DE
(EUCTR)
04/05/201011/03/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 14.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
6EUCTR2009-018167-26-AT
(EUCTR)
15/04/201016/02/2010An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES ExtensionAn extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - IMPRES Extension Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 12.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;Italy;United Kingdom
7EUCTR2009-012057-38-NL
(EUCTR)
05/01/201023/11/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
8EUCTR2009-012057-38-FR
(EUCTR)
21/09/200907/07/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
200France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
9EUCTR2009-012057-38-BE
(EUCTR)
18/09/200922/07/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
10EUCTR2009-012057-38-GB
(EUCTR)
18/08/200915/07/2010A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
11EUCTR2009-012057-38-DE
(EUCTR)
13/08/200910/06/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR =800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec® 100 mg Filmtabletten
Product Code: QTI571
INN or Proposed INN: Imatinib mesilate
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
12EUCTR2009-012057-38-SE
(EUCTR)
12/08/200908/07/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR>1000 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
13EUCTR2009-012057-38-AT
(EUCTR)
17/07/200915/06/2009A 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRESA 24-week randomized placebo-controlled, double-blind multi-center clinical trial evaluating the efficacy and safety of oral QTI571 as an add-on therapy in the treatment of severe pulmonary arterial hypertension: Imatinib in Pulmonary arterial hypertension, a Randomized, Efficacy Study - IMPRES Pulmonary arterial hypertension (PAH) patients who have a PVR=800 dynes.sec.cm-5 despite treatment with two or more specific PAH therapies
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: Glivec®
Product Code: QTI571
INN or Proposed INN: IMATINIB MESYLATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden