Aficamten ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
58肥大型心筋症7

58. 肥大型心筋症


臨床試験数 : 126 薬物数 : 135 - (DrugBank : 42) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 162
No.TrialIDDate_
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PhaseCountries
1EUCTR2020-003571-17-DK
(EUCTR)
21/12/202231/10/2022This study is performed to collect long term safety and tolerability of aficamten (CK-3773274) on patients with symptomatic hypertrophic cardiomyopathy (HCM)An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM). symptomatic hypertrophic cardiomyopathy (HCM)
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Aficamten
Product Code: CK-3773274
INN or Proposed INN: Aficamten
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Product Name: Aficamten
Product Code: CK-3773274
INN or Proposed INN: Aficamten
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Cytokinetics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Poland;Denmark;Netherlands;Germany
2EUCTR2021-003536-92-PL
(EUCTR)
30/05/202220/04/2022A Phase 3 trial to measure how safe and effective CK-3773274 is in Adults with obstructive hypertrophic cardiomyopathy (oHCM)A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction obstructive hypertrophic cardiomyopathy (oHCM)
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: aficamten
Product Code: CK-3773274
INN or Proposed INN: aficamten
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Cytokinetics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Portugal;Czechia;Spain;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;China
3EUCTR2021-003536-92-HU
(EUCTR)
09/05/202223/02/2022A Phase 3 trial to measure how safe and effective CK3773274 is in Adults with obstructive hypertrophic cardiomyopathy (oHCM)A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction obstructive hypertrophic cardiomyopathy (oHCM)
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: aficamten
Product Code: CK-3773274
INN or Proposed INN: aficamten
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Cytokinetics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands;China
4EUCTR2021-003536-92-ES
(EUCTR)
28/04/202211/03/2022A Phase 3 trial to measure how safe and effective CK3773274 is in Adults with obstructive hypertrophic cardiomyopathy (oHCM)A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction obstructive hypertrophic cardiomyopathy (oHCM)
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: aficamten
Product Code: CK-3773274
INN or Proposed INN: aficamten
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Cytokinetics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Portugal;Czechia;Spain;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;China
5EUCTR2021-003536-92-DK
(EUCTR)
08/04/202209/03/2022A Phase 3 trial to measure how safe and effective CK3773274 is in Adults with obstructive hypertrophic cardiomyopathy (oHCM)A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction obstructive hypertrophic cardiomyopathy (oHCM)
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: aficamten
Product Code: CK-3773274
INN or Proposed INN: aficamten
Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE
Cytokinetics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands;China
6NCT05186818
(ClinicalTrials.gov)
February 1, 202223/12/2021CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCMA Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract ObstructionObstructive Hypertrophic Cardiomyopathy (oHCM)Drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg);Drug: Placebo to match CK-3773274CytokineticsJi Xing Pharmaceuticals (Shanghai) Co., Ltd.Recruiting18 Years85 YearsAll270Phase 3United States;China;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
7NCT04848506
(ClinicalTrials.gov)
May 6, 20219/4/2021CY 6022 is an Open Label Study to Collect Long-term Safety and Tolerability Data for Aficamten (CK-3773274)An Open-Label Study of CK-3773274 for Patients With Symptomatic Hypertrophic Cardiomyopathy (HCM)Symptomatic Hypertrophic Cardiomyopathy (HCM)Drug: CK-3773274 (5 - 20 mg)CytokineticsNULLEnrolling by invitation18 Years85 YearsAll300Phase 2Italy;United States;Poland;Spain