86. 肺動脈性肺高血圧症 Pulmonary arterial hypertension Clinical trials / Disease details


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

  
34 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2021-001910-13-FR
(EUCTR)
21/02/202223/12/2021Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial (IMPAHCT) or A Phase 2b/3, Randomized, Controlled, 24-week Dose Ranging and Confirmatory Study of AV-101 in Patients with PAH.IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients with Pulmonary Arterial Hypertension (PAH). - IMPAHCT Pulmonary Arterial Hypertension (PAH)
MedDRA version: 21.1;Level: PT;Classification code 10064911;Term: Pulmonary arterial hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Level: LLT;Classification code 10077729;Term: Pulmonary arterial hypertension WHO functional class III;Classification code 10077730;Term: Pulmonary arterial hypertension WHO functional class IV;Classification code 10077740;Term: Pulmonary arterial hypertension WHO functional class II;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: AV-101
INN or Proposed INN: IMATINIB
Other descriptive name: Not Available
Product Name: AV-101
INN or Proposed INN: IMATINIB
Other descriptive name: Not Available
Product Name: AV-101
INN or Proposed INN: IMATINIB
Other descriptive name: Not Available
Aerovate Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
462Phase 2;Phase 3United States;Portugal;Greece;Spain;Chile;Israel;Colombia;Italy;France;Australia;South Africa;Netherlands;China;Czechia;Turkey;Austria;United Kingdom;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Germany;Sweden
2NCT05036135
(ClinicalTrials.gov)
December 2, 202116/8/2021A Study of AV-101 (Dry Powder Inhaled Imatinib) in Patients With Pulmonary Arterial Hypertension (PAH)IMPAHCT: A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Ranging and Confirmatory Study to Evaluate the Safety and Efficacy of AV-101 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary Arterial HypertensionDrug: AV-101;Drug: PlaceboAerovate TherapeuticsNULLRecruiting18 Years75 YearsAll462Phase 2/Phase 3United States
3NCT04903730
(ClinicalTrials.gov)
May 24, 202124/5/2021Safety, Tolerability, & Pharmacokinetics Study of Single & Multiple Inhaled Doses of Imatinib Inhalation SolutionA Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Inhaled Doses of Imatinib Inhalation Solution (AER-901) in Adult Healthy VolunteersPulmonary Arterial HypertensionDrug: AER-901 Solution for Nebulization;Drug: PlaceboAerami TherapeuticsNULLRecruiting18 Years60 YearsAll78Phase 1Australia
4NCT04416750
(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
5EUCTR2020-001157-48-GB
(EUCTR)
28/07/202009/07/2020PIPAH study: Using imatinib (drug) in Pulmonary Arterial HypertensionIdentifying a safe and tolerated dose of Imatinib forpatients with Pulmonary Arterial Hypertension (PAH) - Positioning Imatinib for Pulmonary Arterial Hypertension (PIPAH) Pulmonary Arterial Hypertension (Idiopathic, heritable, or assosicated with anorexigens)
MedDRA version: 21.1;Level: LLT;Classification code 10036727;Term: Primary pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.1;Level: PT;Classification code 10037400;Term: Pulmonary hypertension;Classification code 10068739;Term: Chronic thromboembolic pulmonary hypertension;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10050701;Term: Congenital pulmonary hypertension;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Imatinib mesilate
Product Name: Imatinib mesilate
INN or Proposed INN: Imatinib mesilate
Imperial College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
43Phase 2United Kingdom
6JPRN-JapicCTI-142462
01/1/201403/03/2014An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatmentAn open-label, multi-center protocol to provide QTI571 to PAH patients who participated in the extension study (A2301E1) in Japan and are judged by the investigator to benefit from continued QTI571 treatment pulmonary arterial hypertensionIntervention name : QTI571
INN of the intervention : imatinib
Dosage And administration of the intervention : QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day
Novartis Pharma K.K.NULLBOTHPhase 3NULL
7EUCTR2013-001100-10-ES
(EUCTR)
12/11/201312/11/2013This study is to allow continued access to QTI571 for patients whoreceived QTI571 for pulmonary arterial hypertension in one of thelong-term extension studies (A2301E1, A2102E1 and E2203) andhave been judged by the investigator to benefit from continuedQTI571 treatment.An open-label, multi-center protocol to provide QTI571 to PAH patients who participated in one of the extension studies and are judged by the investigator to benefit from continued QTI571 treatment Pulmonary Arterial Hypertension
MedDRA version: 16.1;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]
Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
Product Name: Imatinib mesilate
Product Code: QTI571
INN or Proposed INN: IMATINIB MESILATE
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
81United States;Spain;Australia;Switzerland
8NCT01392495
(ClinicalTrials.gov)
June 201111/7/2011Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An 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 HypertensionPulmonary Arterial HypertensionDrug: ImatinibNovartis PharmaceuticalsNULLTerminatedN/AN/AAll17Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Turkey
9NCT01392469
(ClinicalTrials.gov)
April 20, 201110/5/2011Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension ParticipantsA 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) PatientsPulmonary Arterial HypertensionDrug: Imatinib;Drug: Sildenafil;Drug: BosentanNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll21Phase 3United States;Australia;Belgium;Germany;Italy;Lithuania;United Kingdom;Romania;Turkey
10EUCTR2010-021960-14-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
11EUCTR2010-021960-14-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
12EUCTR2010-021344-17-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
13EUCTR2009-018167-26-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
14EUCTR2009-018167-26-IT
(EUCTR)
20/09/201014/07/2010An 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 Extension - NDAn 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 - ND pulmonary arterial hypertension
MedDRA version: 9.1;Level: PT;Classification code 10037400
Trade Name: GLIVEC
INN or Proposed INN: IMATINIB
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
140France;Belgium;Spain;Austria;Germany;United Kingdom;Italy
15EUCTR2009-018167-26-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
16EUCTR2009-018167-26-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
17EUCTR2009-018167-26-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
18EUCTR2009-018167-26-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
19NCT01117987
(ClinicalTrials.gov)
April 20103/5/2010Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH)An Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Oral QTI571 (Imatinib) in the Treatment of Severe Pulmonary Arterial Hypertension: IMPRES ExtensionPulmonary Arterial HypertensionDrug: Imatinib;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 YearsN/AAll144Phase 3United States;Austria;Belgium;Canada;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Spain;Switzerland;United Kingdom;Sweden
20EUCTR2009-012057-38-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
21EUCTR2009-012057-38-IT
(EUCTR)
06/11/200930/10/2009A 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 (IMPRES) - NDA 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) - ND Pulmonary arterial hypertension,
MedDRA version: 9.1;Level: PT;Classification code 10037400
Trade Name: GLIVEC
INN or Proposed INN: Imatinib
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden
22EUCTR2009-012057-38-ES
(EUCTR)
02/10/200902/07/2009Ensayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRESEnsayo clínico multicéntrico, aleatorizado controlado con placebo, doble ciego y de 24 semanas de duración, para evaluar la eficacia y seguridad de QTI571 oral como terapia adicional en el tratamiento de la hipertensión arterial pulmonar severa: Imatinib en hipertensión arterial pulmonar, un estudio aleatorizado de eficacia (IMPRES) - IMPRES Pacientes con Hipertensión Arterial Pulmonar (HAP) que tienen una RVP>1000 dynes.sec.cm-5 a pesar de estar en tratamiento con dos o mas terapias específicas para la HAP.
MedDRA version: 9.1;Level: LLT;Classification code 10064911;Term: Pulmonary arterial hypertension
Trade Name: GLIVEC 100 mg comprimidos recubiertos con película
INN or Proposed INN: IMATINIB
Other descriptive name: IMATINIB
Novartis Farmacéutica SANULLNot RecruitingFemale: yes
Male: yes
200France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
23EUCTR2009-012057-38-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
24EUCTR2009-012057-38-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
25NCT00902174
(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
26EUCTR2009-012057-38-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
27EUCTR2009-012057-38-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
28EUCTR2009-012057-38-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
29EUCTR2009-012057-38-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
30JPRN-UMIN000001578
2008/12/0116/12/2008Tyrosine Kinase Inhibitor for the Treatment of Severe Pulmonary Arterial Hypertension pulmonary arterial hypertensionadministration of tyrosine kinase inhibitor (imatinib)Medical Education CenterNULL20years-oldNot applicableMale and Female10Not selectedJapan
31EUCTR2005-005569-12-AT
(EUCTR)
11/08/200613/07/2006A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. pulmonary arterial hypertensionProduct Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
Austria;Germany;United Kingdom
32EUCTR2005-005569-12-DE
(EUCTR)
24/05/200627/03/2006A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. pulmonary arterial hypertensionTrade Name: Glivec 100 mg Hartkapsel
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Trade Name: Glivec 100 mg Filmtabletten
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Austria;Germany;United Kingdom
33NCT00477269
(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
34EUCTR2005-005569-12-GB
(EUCTR)
26/01/200602/12/2005A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension.A randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of six months treatment with the tyrosine kinase inhibitor of STI571 for the treatment of pulmonary arterial hypertension. pulmonary arterial hypertensionTrade Name: Glivec
Product Name: Glivec
Product Code: STI571
INN or Proposed INN: Imatinib
Product Code: STI571
INN or Proposed INN: Imatinib
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Austria;Germany;United Kingdom