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. | 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 | EUCTR2020-003571-17-DK (EUCTR) | 21/12/2022 | 31/10/2022 | This 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Poland;Denmark;Netherlands;Germany | ||
| 2 | EUCTR2021-003536-92-PL (EUCTR) | 30/05/2022 | 20/04/2022 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Portugal;Czechia;Spain;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Netherlands;Germany;China | ||
| 3 | EUCTR2021-003536-92-HU (EUCTR) | 09/05/2022 | 23/02/2022 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands;China | ||
| 4 | EUCTR2021-003536-92-ES (EUCTR) | 28/04/2022 | 11/03/2022 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Portugal;Czechia;Spain;Israel;United Kingdom;Italy;France;Hungary;Poland;Denmark;Germany;Netherlands;China | ||
| 5 | EUCTR2021-003536-92-DK (EUCTR) | 08/04/2022 | 09/03/2022 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Hungary;Poland;Denmark;Germany;Netherlands;China | ||
| 6 | NCT05186818 (ClinicalTrials.gov) | February 1, 2022 | 23/12/2021 | CY 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 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) | Drug: CK-3773274 (5 mg, 10 mg, 15 mg and 20 mg);Drug: Placebo to match CK-3773274 | Cytokinetics | Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Recruiting | 18 Years | 85 Years | All | 270 | Phase 3 | United States;China;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom |
| 7 | NCT04848506 (ClinicalTrials.gov) | May 6, 2021 | 9/4/2021 | CY 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) | Cytokinetics | NULL | Enrolling by invitation | 18 Years | 85 Years | All | 300 | Phase 2 | Italy;United States;Poland;Spain |