SB-497115-GR ( DrugBank: - )
1 disease
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 63 | Idiopathic thrombocytopenic purpura | 37 |
63. Idiopathic thrombocytopenic purpura
Clinical trials : 363 / Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138
| 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 | EUCTR2009-010421-39-FR (EUCTR) | 25/05/2010 | 09/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;Hungary;Czech Republic;Germany;Italy | ||
| 2 | EUCTR2009-010421-39-CZ (EUCTR) | 06/05/2010 | 03/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Hungary;Czech Republic;Germany;Italy | |||
| 3 | EUCTR2009-010421-39-HU (EUCTR) | 05/05/2010 | 10/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Czech Republic;Hungary;Germany;Italy | |||
| 4 | EUCTR2009-010421-39-DE (EUCTR) | 10/03/2010 | 04/02/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Hungary;Czech Republic;Germany;Italy | |||
| 5 | EUCTR2006-000471-14-IE (EUCTR) | 02/08/2008 | 05/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2006-000471-14-FI (EUCTR) | 30/11/2007 | 08/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 7 | EUCTR2006-000471-14-IT (EUCTR) | 16/11/2007 | 13/09/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | Idiopathic thrombocytopenic purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag | GLAXOSMITHKLINE R&D LTD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 8 | EUCTR2006-000471-14-AT (EUCTR) | 11/11/2007 | 23/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 9 | EUCTR2006-000471-14-DE (EUCTR) | 26/10/2007 | 30/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 10 | EUCTR2006-000471-14-DK (EUCTR) | 01/10/2007 | 14/08/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 11 | EUCTR2006-000470-78-CZ (EUCTR) | 01/10/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 12 | NCT00540423 (ClinicalTrials.gov) | September 2007 | 5/10/2007 | Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- | Chronic Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, Idiopathic | Drug: SB-497115-GR 12.5mg;Drug: SB-497115-GR 25mg;Drug: SB-497115-GR 12.5mg matching placebo;Drug: SB-497115-GR 50 mg | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 23 | Phase 3 | Japan |
| 13 | EUCTR2006-000471-14-CZ (EUCTR) | 16/08/2007 | 24/07/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 14 | EUCTR2006-002943-10-ES (EUCTR) | 19/04/2007 | 21/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Spain;Germany;United Kingdom | ||
| 15 | EUCTR2006-002943-10-GB (EUCTR) | 13/04/2007 | 26/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom | ||
| 16 | EUCTR2006-000470-78-GR (EUCTR) | 27/03/2007 | 03/01/2007 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 17 | EUCTR2006-002943-10-DE (EUCTR) | 16/03/2007 | 28/03/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | United Kingdom;Germany;Spain | |||
| 18 | NCT00424177 (ClinicalTrials.gov) | March 2007 | 17/1/2007 | Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) | An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States |
| 19 | EUCTR2006-000471-14-GR (EUCTR) | 27/02/2007 | 04/09/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 20 | EUCTR2006-000470-78-DE (EUCTR) | 14/02/2007 | 05/12/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Czech Republic;Germany;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 21 | EUCTR2006-000471-14-SK (EUCTR) | 23/01/2007 | 30/11/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 17.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 22 | EUCTR2006-000470-78-SK (EUCTR) | 17/01/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 23 | EUCTR2006-000470-78-IT (EUCTR) | 17/01/2007 | 05/02/2007 | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | Idiopathic thrombocytopenic purpura ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR Product Name: Eltrombopag Product Code: SB-497115-GR | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 24 | EUCTR2006-000470-78-FR (EUCTR) | 22/12/2006 | 16/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 25 | EUCTR2006-000470-78-FI (EUCTR) | 12/12/2006 | 25/10/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 26 | EUCTR2006-000470-78-DK (EUCTR) | 29/11/2006 | 10/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 27 | EUCTR2006-000470-78-GB (EUCTR) | 22/11/2006 | 08/05/2008 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom | ||
| 28 | EUCTR2006-000470-78-ES (EUCTR) | 22/11/2006 | 13/04/2012 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Russian Federation;Italy;Vietnam;India;France;Denmark;Peru;Netherlands;Tunisia;China;Finland;Austria;United Kingdom;Czech Republic;Canada;Brazil;Poland;Germany;New Zealand | ||
| 29 | EUCTR2006-000470-78-AT (EUCTR) | 22/11/2006 | 20/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 30 | NCT00370331 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag | A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 197 | Phase 3 | United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia |
| 31 | EUCTR2006-000470-78-NL (EUCTR) | 30/10/2006 | 01/09/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 32 | EUCTR2006-000471-14-GB (EUCTR) | 23/10/2006 | 03/06/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune Thrombocytopenic Purpura (ITP) MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 33 | EUCTR2006-000471-14-NL (EUCTR) | 23/08/2006 | 21/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 34 | EUCTR2006-000471-14-SE (EUCTR) | 14/08/2006 | 29/05/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 18.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 35 | EUCTR2006-000471-14-FR (EUCTR) | 16/06/2006 | 24/11/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 36 | EUCTR2006-000471-14-SI (EUCTR) | 13/06/2006 | 23/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece | |||
| 37 | NCT00351468 (ClinicalTrials.gov) | June 2006 | 10/7/2006 | EXTEND (Eltrombopag Extended Dosing Study) | EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag olamine (SB-497115-GR) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 302 | Phase 3 | United States;Australia;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Italy;Korea, Republic of;Netherlands;New Zealand;Pakistan;Peru;Poland;Romania;Russian Federation;Slovakia;Slovenia;Spain;Sweden;Taiwan;Thailand;Tunisia;Ukraine;United Kingdom;Vietnam;India;Ireland;Mexico;Norway |