58. 肥大型心筋症 Hypertrophic cardiomyopathy Clinical trials / Disease details
臨床試験数 : 119 / 薬物数 : 163 - (DrugBank : 45) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 161
| 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 | 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 |
| 2 | EUCTR2020-003571-17-IT (EUCTR) | 30/11/2021 | 02/09/2021 | An Open-Label Study of CK3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction | An Open-Label Study of CK3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract Obstruction - na | 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: n/a Product Code: [CK-3773274] INN or Proposed INN: CK-3773274 Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE Product Name: n/a Product Code: [CK-3773274] INN or Proposed INN: CK-3773274 Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1HPYRAZOLE-4-CARBOXAMIDE | CYTOKINETICS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Spain;Italy | ||
| 3 | EUCTR2020-003571-17-ES (EUCTR) | 11/08/2021 | 14/07/2021 | This study is being performed to collect long-term safety and tolerability data of CK-3773274 on patients with obstructive hypertrophic cardiomyopathy (oHCM). | An Open-Label Study of CK-3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 | 54 | Phase 2 | United States;Spain;Italy | ||
| 4 | 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 | United States;Italy;Spain |
| 5 | NCT04783766 (ClinicalTrials.gov) | April 10, 2021 | 3/3/2021 | Safety, Tolerability and Pharmacokinetics Study of CK-3773274 | A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese Subjects | Obstructive Hypertrophic Cardiomyopathy;Healthy Adult Subjects | Drug: CK-3773274;Drug: Placebo | Ji Xing Pharmaceuticals (Shanghai) Co., Ltd. | Cytokinetics | Completed | 18 Years | 45 Years | All | 28 | Phase 1 | China |
| 6 | EUCTR2019-002785-12-ES (EUCTR) | 25/05/2020 | 20/12/2019 | Pharmacokinetic and Pharmacodynamic study to evaluate the effect of CK-3773274 in patients with obstructive hypertrophic cardiomyopathy (oHCM) | A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 | 60 | Phase 2 | United States;Spain;Netherlands;United Kingdom;Italy | ||
| 7 | EUCTR2019-002785-12-GB (EUCTR) | 08/05/2020 | 31/12/2019 | Pharmacokinetic and Pharmacodynamic study to evaluate the effect of CK-3773274 in patients with obstructive hypertrophic cardiomyopathy (oHCM) | A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 | 60 | Phase 2 | United States;Spain;Netherlands;Italy;United Kingdom | ||
| 8 | EUCTR2019-002785-12-IT (EUCTR) | 31/03/2020 | 04/02/2021 | Pharmacokinetic and Pharmacodynamic study to evaluate the effect of CK3773274 in patients with obstructive hypertrophic cardiomyopathy (oHCM) | A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CK-3773274 in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction - N/A | 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: n/a Product Code: [CK-3773274] INN or Proposed INN: CK-3773274 Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE Product Name: n/a Product Code: [CK-3773274] INN or Proposed INN: CK-3773274 Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE Product Name: n/a Product Code: [CK-3773274] INN or Proposed INN: CK-3773274 Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE Product Name: n/a Product Code: [CK-3773274] INN or Proposed INN: CK-3773274 Other descriptive name: (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1METHYL-1H-PYRAZOLE-4-CARBOXAMIDE | CYTOKINETICS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Spain;Netherlands;United Kingdom;Italy | ||
| 9 | NCT04219826 (ClinicalTrials.gov) | January 10, 2020 | 3/1/2020 | REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease in HCM | A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction | Obstructive Hypertrophic Cardiomyopathy | Drug: CK-3773274 (5 - 15 mg);Drug: CK-3773274 (10 - 30 mg);Drug: Placebo for CK-3773274 | Cytokinetics | NULL | Recruiting | 18 Years | 85 Years | All | 48 | Phase 2 | United States;Italy;Netherlands;Spain |
| 10 | NCT03767855 (ClinicalTrials.gov) | December 4, 2018 | 3/12/2018 | A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects | A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult Subjects | Symptomatic Obstructive Hypertrophic Cardiomyopathy;Healthy Subjects | Drug: CK-3773274 - Granules in Capsule;Drug: Placebo - Granules in Capsule;Drug: CK-3773274 - Tablets | Cytokinetics | NULL | Completed | 18 Years | 55 Years | All | 114 | Phase 1 | United States |
| 11 | EUCTR2019-002785-12-NL (EUCTR) | 20/01/2020 | Pharmacokinetic and Pharmacodynamic study to evaluate the effect of CK-3773274 in patients with obstructive hypertrophic cardiomyopathy (oHCM) | A multi-center, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 Code: CK-3773274 INN or Proposed INN: CK-3773274 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 | 60 | Phase 2 | United States;Italy;United Kingdom;Netherlands;Spain |