AKR-501, YM-477 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
63特発性血小板減少性紫斑病13

63. 特発性血小板減少性紫斑病


臨床試験数 : 391 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 139
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000830-12-GR
(EUCTR)
16/11/201208/10/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 15.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hong Kong;Slovakia;Greece;Ukraine;Czech Republic;Poland;Belgium;Singapore;Romania;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
2EUCTR2011-000830-12-NL
(EUCTR)
28/08/201223/08/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand
3EUCTR2011-000831-10-DE
(EUCTR)
18/07/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
4EUCTR2011-000831-10-BE
(EUCTR)
16/07/201215/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
5EUCTR2011-000831-10-GB
(EUCTR)
02/07/201228/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
6EUCTR2011-000831-10-AT
(EUCTR)
05/06/201216/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
7EUCTR2011-000831-10-ES
(EUCTR)
25/05/201229/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden
8EUCTR2011-000831-10-NL
(EUCTR)
24/05/201224/05/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag maleate
Other descriptive name: AKR-501, YM-477
Trade Name: Revolade 25 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Trade Name: Revolade 50 mg film-coated tablets
INN or Proposed INN: eltrombopag
Other descriptive name: eltrombopag olamine, Revolade, Promacta
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
286Phase 3United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of
9EUCTR2011-000830-12-CZ
(EUCTR)
19/01/201203/11/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Poland;Belgium;Ukraine;Singapore;Australia;South Africa;Bulgaria;Netherlands;New Zealand
10EUCTR2011-000830-12-PL
(EUCTR)
16/01/201217/11/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Slovakia;Greece;Ukraine;Austria;Czech Republic;Poland;Belgium;Singapore;Romania;South Africa;Bulgaria;Netherlands;New Zealand
11EUCTR2011-000830-12-BE
(EUCTR)
30/12/201120/09/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hungary;Czech Republic;Belgium;Poland;Portugal;Hong Kong;Slovakia;Greece;Ukraine;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
12EUCTR2011-000830-12-BG
(EUCTR)
21/12/201112/12/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Hong Kong;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;South Africa;Netherlands;New Zealand;China
13EUCTR2011-000830-12-SK
(EUCTR)
28/09/201126/08/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China