IMATINIB MESYLATE ( DrugBank: Imatinib )


5 diseases
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎1
28全身性アミロイドーシス1
34神経線維腫症4
51全身性強皮症7
86肺動脈性肺高血圧症16

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03674099
(ClinicalTrials.gov)
October 1, 201814/9/2018Imatinib for Multiple Sclerosis (MS) RelapsesImatinib for Multiple Sclerosis (MS) Relapses - a Phase II, Randomised StudyMultiple SclerosisDrug: Imatinib Mesylate;Drug: MethylprednisoloneTomas OlssonThe Swedish Research CouncilRecruiting18 Years55 YearsAll200Phase 2Denmark;Germany;Norway;Sweden

28. 全身性アミロイドーシス


臨床試験数 : 267 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00025415
(ClinicalTrials.gov)
August 200111/10/2001Imatinib Mesylate in Treating Patients With Advanced Cancer and Liver DysfunctionA Phase I Pharmacokinetic Study of STI571 in Patients With Advanced Malignancies and Varying Levels of Liver DysfunctionAccelerated Phase Chronic Myelogenous Leukemia;Acute Undifferentiated Leukemia;AIDS-related Peripheral/Systemic Lymphoma;AIDS-related Primary CNS Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative;Blastic Phase Chronic Myelogenous Leukemia;Childhood Myelodysplastic Syndromes;Chronic Eosinophilic Leukemia;Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;de Novo Myelodysplastic Syndromes;Essential Thrombocythemia;Extramedullary Plasmacytoma;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Gastrointestinal Stromal Tumor;Intraocular Lymphoma;Isolated Plasmacytoma of Bone;Meningeal Chronic Myelogenous Leukemia;Monoclonal Gammopathy of Undetermined Significance;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Polycythemia Vera;Previously Treated Myelodysplastic Syndromes;Primary Central Nervous System Non-Hodgkin Lymphoma;Primary Myelofibrosis;Primary Systemic Amyloidosis;Progressive Hairy Cell Leukemia, Initial Treatment;Prolymphocytic Leukemia;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Relapsing Chronic Myelogenous Leukemia;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Small Intestine Lymphoma;Splenic Marginal Zone Lymphoma;Stage IV Adult Burkitt Lymphoma;Stage IV Adult Diffuse Large Cell Lymphoma;Stage IV Adult Diffuse Mixed Cell Lymphoma;Stage IV Adult Diffuse Small Cleaved Cell Lymphoma;Stage IV Adult Hodgkin Lymphoma;Stage IV Adult Immunoblastic Large Cell Lymphoma;Stage IV Adult Lymphoblastic Lymphoma;Stage IV Adult T-cell Leukemia/Lymphoma;Stage IV Chronic Lymphocytic Leukemia;Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma;Stage IV Grade 1 Follicular Lymphoma;Stage IV Grade 2 Follicular Lymphoma;Stage IV Grade 3 Follicular Lymphoma;Stage IV Mantle Cell Lymphoma;Stage IV Marginal Zone Lymphoma;Stage IV Mycosis Fungoides/Sezary Syndrome;Stage IV Small Lymphocytic Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Unspecified Adult Solid Tumor, Protocol Specific;Untreated Adult Acute Lymphoblastic Leukemia;Untreated Adult Acute Myeloid Leukemia;Untreated Hairy Cell Leukemia;Waldenström MacroglobulinemiaDrug: imatinib mesylate;Other: pharmacological studyNational Cancer Institute (NCI)NULLCompleted15 YearsN/ABoth60Phase 1United States

34. 神経線維腫症


臨床試験数 : 133 薬物数 : 186 - (DrugBank : 67) / 標的遺伝子数 : 79 - 標的パスウェイ数 : 190
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03688568
(ClinicalTrials.gov)
September 1, 201811/9/2018Study of Imatinib in Children With Neurofibromatosis and Airway TumorsPhase 2 Study of Imatinib in Children With Neurofibromatosis and Airway TumorsNeurofibroma, PlexiformDrug: Imatinib MesylateIndiana UniversityNULLWithdrawn6 Months12 YearsAll0Phase 2United States
2NCT02177825
(ClinicalTrials.gov)
June 201425/6/2014Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform NeurofibromasPhase II Study of Imatinib Mesylate in Neurofibromatosis Type I Patients Aged 2 to 21 With Plexiform NeurofibromasPlexiform NeurofibromasDrug: Imatinib MesylateSt. Justine's HospitalNULLTerminated2 Years21 YearsAll5Phase 2Canada
3NCT01140360
(ClinicalTrials.gov)
February 20128/6/2010Pilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform NeurofibromasPilot Study of Gleevec/Imatinib Mesylate (STI-571, NSC 716051) in Neurofibromatosis (NF1) Patient With Plexiform NeurofibromasNeurofibromatosis;NeurofibromasDrug: GleevecKent RobertsonNULLCompleted3 Years65 YearsAll21Phase 1/Phase 2United States
4NCT01673009
(ClinicalTrials.gov)
May 200622/8/2012Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform NeurofibromasPhase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform NeurofibromasNeurofibromatosisDrug: GleevecIndiana UniversityNULLCompleted3 Years65 YearsAll36Phase 2United States

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
1NCT01309997
(ClinicalTrials.gov)
March 20111/3/2011Imatinib and Rituximab in Treating Cutaneous Sclerosis in Patients With Chronic Graft-Versus-Host DiseaseA Randomized Phase II Study of Imatinib and Rituximab for Cutaneous Sclerosis After Allogeneic Hematopoietic Cell TransplantationGraft Versus Host Disease;Systemic SclerodermaDrug: imatinib mesylate;Biological: rituximabLee, StephanieNational Cancer Institute (NCI)Completed2 YearsN/AAll72Phase 2United States
2NCT01545427
(ClinicalTrials.gov)
April 20081/3/2012Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse SclerodermaA Proof of Concept Trial of Gleevec (Imatinib) in Active Diffuse SclerodermaSclerodermaDrug: Imatinib mesylate;Other: PlaceboLawson Health Research InstituteNovartis PharmaceuticalsTerminated18 YearsN/ABoth10Phase 2Canada
3NCT00613171
(ClinicalTrials.gov)
January 2, 200825/1/2008Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic SclerosisA Multi-centre, Open-label, Proof of Concept (PoC) Study to Evaluate the Efficacy and Tolerability of STI571 for the Treatment of Fibrosis in Patients With Systemic SclerosisSystemic Sclerosis, SclerodermaDrug: STI571Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll27Phase 2United States;Germany;Italy;Switzerland;United Kingdom
4NCT00479934
(ClinicalTrials.gov)
December 200729/5/2007Efficacy and Safety of Imatinib in SclerodermaPhase II Randomized Double Blind Clinical Trial of'Imatinib Mesylate STI571 (Glivec®) Versus Placebo in Patients With Severe Cutaneous Scleroderma or Systemic Sclerosis With Severe Cutaneous Involvement.Scleroderma, Localized;Scleroderma, SystemicDrug: imatinib mesylateUniversity Hospital, BordeauxMinistry of Health, France;NovartisCompleted18 YearsN/ABoth28Phase 2France
5EUCTR2006-007091-15-NL
(EUCTR)
03/09/200702/04/2007Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosisGlivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis systemic sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10039710;Term: Scleroderma
Product Name: GlivecErasmusMCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Netherlands
6NCT00555581
(ClinicalTrials.gov)
August 20077/11/2007Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisPhase IIA Study of the Safety and Tolerability of the Use of Imatinib Mesylate (Gleevec) in the Treatment of Systemic SclerosisSystemic SclerosisDrug: Imatinib MesylateHospital for Special Surgery, New YorkNovartis PharmaceuticalsCompleted18 YearsN/AAll30Phase 2United States
7NCT00506831
(ClinicalTrials.gov)
July 200724/7/2007Imatinib in Systemic SclerosisA Pilot Study of Imatinib in the Treatment of Refractory Systemic SclerosisScleroderma, SystemicDrug: Imatinib mesylateStanford UniversityNULLCompleted18 Years80 YearsAll9Phase 1/Phase 2United States

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
1NCT04416750
(ClinicalTrials.gov)
January 20, 202128/5/2020Positioning Imatinib for Pulmonary Arterial HypertensionPositioning Imatinib for Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Imatinib MesylateImperial College LondonNational Institute for Health Research, United Kingdom;Medical Research Council;University of Cambridge;University of SheffieldRecruiting18 Years80 YearsAll43Phase 2United Kingdom
2EUCTR2010-021960-14-IT
(EUCTR)
11/03/201126/05/2011An open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - NDAn open-label extension study to CQTI571A2102 to evaluate the long-term safety, tolerability and efficacy ofQTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 13.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
20Germany;Italy
3EUCTR2010-021344-17-IT
(EUCTR)
28/01/201107/02/2011A non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - NDA non-randomized, multiple dose, three treatment period, open-label, single sequence, single group study to evaluate the pharmacokinetic effect of two doses of QTI571 (imatinib) on the co-administered drugs sildenafil and bosentan in pulmonary arterial hypertension (PAH) patients. - ND Pulmonary arterial hypertension (PAH)
MedDRA version: 9.1;Level: LLT;Classification code 10064911
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB MESYLATE
Trade Name: REVATIO
INN or Proposed INN: Sildenafil
Trade Name: TRACLEER
INN or Proposed INN: Bosentan
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
24Italy
4EUCTR2009-018167-26-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
5EUCTR2009-018167-26-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
6EUCTR2009-018167-26-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
7EUCTR2009-018167-26-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
8EUCTR2009-018167-26-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
9EUCTR2009-012057-38-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
10EUCTR2009-012057-38-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
11EUCTR2009-012057-38-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
12NCT00902174
(ClinicalTrials.gov)
September 200913/5/2009Imatinib (QTI571) in Pulmonary Arterial HypertensionA 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 HypertensionDrug: imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll202Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Switzerland;United Kingdom
13EUCTR2009-012057-38-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
14EUCTR2009-012057-38-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
15EUCTR2009-012057-38-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
16NCT00477269
(ClinicalTrials.gov)
April 200622/5/2007Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial HypertensionA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: Imatinib mesylate;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll59Phase 2/Phase 3United States;Austria;Germany;United Kingdom