Glivec (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 | 7 |
86 | 肺動脈性肺高血圧症 | 21 |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2007-004669-17-IT (EUCTR) | 17/12/2008 | 16/06/2008 | A 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 sclerosis - ND | A 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 sclerosis - ND | sistemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10018124;Term: Generalized scleroderma | Trade Name: GLIVEC INN or Proposed INN: IMATINIB MESILATO | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 27 | United Kingdom;Italy | |||
2 | EUCTR2007-004669-17-DE (EUCTR) | 10/07/2008 | 13/03/2008 | A 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 sclerosis | A 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 sclerosis | systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Glivec 100 mg Filmtabletten Product Name: Glivec Product Code: STI571 INN or Proposed INN: imatinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 27 | Germany;Italy;United Kingdom | |||
3 | EUCTR2007-004669-17-GB (EUCTR) | 15/02/2008 | 16/10/2007 | A multi-center, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis | A multi-center, open-label, Proof of Concept (PoC) study to evaluate the efficacy and tolerability of STI571 for the treatment of fibrosis in patients with systemic sclerosis | Skin fibrosis in systemic sclerosis patients MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Glivec Product Name: Glivec Product Code: STI571 INN or Proposed INN: imatinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 27 | United Kingdom;Italy | |||
4 | NCT00479934 (ClinicalTrials.gov) | December 2007 | 29/5/2007 | Efficacy and Safety of Imatinib in Scleroderma | Phase 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, Systemic | Drug: imatinib mesylate | University Hospital, Bordeaux | Ministry of Health, France;Novartis | Completed | 18 Years | N/A | Both | 28 | Phase 2 | France |
5 | EUCTR2007-005322-68-IT (EUCTR) | 30/10/2007 | 04/10/2007 | Low-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in scleroderma | Low-dose oral imatinib in the treatment of scleroderma pulmonary involvement: a phase II pilot study - Imatinib in scleroderma | Systemic Sclerosis MedDRA version: 6.1;Level: PT;Classification code 10042953 | Trade Name: GLIVEC INN or Proposed INN: Imatinib | AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Italy | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | EUCTR2007-001508-19-IT (EUCTR) | 06/09/2007 | 29/07/2008 | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | TRATTAMENTO CON IMATINIB MESILATO DELLA GVH CRONICA SEVERA SCLERODERMA-LIKE REFRATTARIA ALLA TERAPIA IMMUNOSOPRESSIVA CONVENZIONALE - ND | GVH CRONICA ESTESA MedDRA version: 9.1;Level: LLT;Classification code 10018651;Term: Graft versus host disease | Trade Name: GLIVEC INN or Proposed INN: Imatinib | AZIENDA OSPEDALIERA S. CARLO | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
7 | EUCTR2006-007091-15-NL (EUCTR) | 03/09/2007 | 02/04/2007 | Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis | Glivec (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: Glivec | ErasmusMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | Netherlands |
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2013-001100-10-ES (EUCTR) | 12/11/2013 | 12/11/2013 | This 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. | NULL | Not Recruiting | Female: yes Male: yes | 81 | United States;Spain;Australia;Switzerland | |||
2 | EUCTR2010-021960-14-DE (EUCTR) | 08/04/2011 | 03/03/2011 | 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 hypertension | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Italy | |||
3 | EUCTR2010-021960-14-IT (EUCTR) | 11/03/2011 | 26/05/2011 | An 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 | An 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany;Italy | |||
4 | EUCTR2010-021344-17-IT (EUCTR) | 28/01/2011 | 07/02/2011 | A 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 | A 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 24 | Italy | |||
5 | EUCTR2009-018167-26-FR (EUCTR) | 04/11/2010 | 13/09/2010 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | EUCTR2009-018167-26-IT (EUCTR) | 20/09/2010 | 14/07/2010 | An 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 | An 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;United Kingdom;Italy | |||
7 | EUCTR2009-018167-26-BE (EUCTR) | 31/08/2010 | 18/05/2010 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 3 | France;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
8 | EUCTR2009-018167-26-DE (EUCTR) | 04/05/2010 | 11/03/2010 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | |||
9 | EUCTR2009-018167-26-AT (EUCTR) | 15/04/2010 | 16/02/2010 | An 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 | An 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;Belgium;Spain;Austria;Germany;Italy;United Kingdom | |||
10 | EUCTR2009-012057-38-NL (EUCTR) | 05/01/2010 | 23/11/2009 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | EUCTR2009-012057-38-IT (EUCTR) | 06/11/2009 | 30/10/2009 | A 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 | A 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
12 | EUCTR2009-012057-38-ES (EUCTR) | 02/10/2009 | 02/07/2009 | Ensayo 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 | Ensayo 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
13 | EUCTR2009-012057-38-FR (EUCTR) | 21/09/2009 | 07/07/2009 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Belgium;Spain;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
14 | EUCTR2009-012057-38-BE (EUCTR) | 18/09/2009 | 22/07/2009 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
15 | EUCTR2009-012057-38-GB (EUCTR) | 18/08/2009 | 15/07/2010 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | EUCTR2009-012057-38-DE (EUCTR) | 13/08/2009 | 10/06/2009 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
17 | EUCTR2009-012057-38-SE (EUCTR) | 12/08/2009 | 08/07/2009 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
18 | EUCTR2009-012057-38-AT (EUCTR) | 17/07/2009 | 15/06/2009 | A 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 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | United Kingdom;Germany;Netherlands;Belgium;France;Spain;Italy;Austria;Sweden | |||
19 | EUCTR2005-005569-12-AT (EUCTR) | 11/08/2006 | 13/07/2006 | 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. | 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 hypertension | Product Name: Glivec Product Code: STI571 INN or Proposed INN: Imatinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | Austria;Germany;United Kingdom | ||||
20 | EUCTR2005-005569-12-DE (EUCTR) | 24/05/2006 | 27/03/2006 | 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. | 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 hypertension | Trade 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Austria;Germany;United Kingdom | |||
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
21 | EUCTR2005-005569-12-GB (EUCTR) | 26/01/2006 | 02/12/2005 | 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. | 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 hypertension | Trade Name: Glivec Product Name: Glivec Product Code: STI571 INN or Proposed INN: Imatinib Product Code: STI571 INN or Proposed INN: Imatinib | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Austria;Germany;United Kingdom |