58. 肥大型心筋症 Hypertrophic cardiomyopathy Clinical trials / Disease details


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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05025644
(ClinicalTrials.gov)
March 202311/8/2021Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress TestQuantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress TestHypertrophic Obstructive CardiomyopathyDrug: Pre and post-CPB Drug: Dobutamine Hydrochloride;Drug: Post-CPB Drug: Dobutamine HydrochlorideUniversity Health Network, TorontoNULLNot yet recruiting18 YearsN/AAll60Phase 4NULL
2EUCTR2021-005329-26-ES
(EUCTR)
26/01/202301/11/2022A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with CardiomyopathyA Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Mavacamten in nonobstructive HCM Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10049813;Term: Non-obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Myokardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Denmark;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of
3EUCTR2021-005329-26-FR
(EUCTR)
24/01/202307/10/2022A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with CardiomyopathyA Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Mavacamten in nonobstructive HCM Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10049813;Term: Non-obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Myokardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Denmark;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of
4NCT05556343
(ClinicalTrials.gov)
January 18, 202323/9/2022A Study to Evaluate the Efficacy, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Obstructive Hypertrophic CardiomyopathyA Phase 2a, Open-label, Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-224 in Participants With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract ObstructionCardiomyopathy, HypertrophicDrug: MYK-224Bristol-Myers SquibbNULLRecruiting18 Years70 YearsAll36Phase 2United States;Italy;Poland;Spain
5EUCTR2020-003571-17-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
6NCT05582395
(ClinicalTrials.gov)
December 14, 202214/9/2022A Study of Mavacamten in Non-Obstructive Hypertrophic CardiomyopathyA Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic CardiomyopathyCardiomyopathy, HypertrophicDrug: Mavacamten;Other: PlaceboBristol-Myers SquibbNULLRecruiting18 YearsN/AAll420Phase 3United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Portugal;Spain;United Kingdom
7NCT05414175
(ClinicalTrials.gov)
August 19, 20227/6/2022A Study of Mavacamten in Obstructive Hypertrophic CardiomyopathyA Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safety and Tolerability of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyCardiomyopathy, Hypertrophic ObstructiveDrug: MavacamtenBristol-Myers SquibbNULLRecruiting18 YearsN/AAll30Phase 3Japan
8NCT05569382
(ClinicalTrials.gov)
August 10, 20224/10/2022Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic CardiomyopathyTreatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic CardiomyopathyNon-obstructive Hypertrophic CardiomyopathyDrug: Verapamil;Drug: Bisoprolol;Drug: PlaceboMorten Steen Kvistholm JensenBispebjerg Hospital;Rigshospitalet, Denmark;Viborg Regional Hospital;Zealand University Hospital;Odense University Hospital;Gentofte University HospitalRecruiting18 YearsN/AAll140Phase 4Denmark
9JPRN-jRCT2031220178
21/06/202202/07/2022A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy( HORIZON-HCM )A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safetyand Tolerability of Mavacamten in Adults With Symptomatic ObstructiveHypertrophic Cardiomyopathy Obstructive Hypertrophic CardiomyopathySingle Group Assignment: Mavacamten
Participants will receive treatment with 1, 2.5, 5, 10, 1mg dose once daily.
Florea VictoriaNULLPending>= 18age oldNot applicableBoth30Phase 3Japan
10NCT05182658
(ClinicalTrials.gov)
June 1, 202221/12/2021Empagliflozin in Hypertrophic CardiomyopathyThe Use of Empagliflozin in Patients With Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy;Heart FailureDrug: Empagliflozin 10 MG;Drug: PlaceboInstitute of Cardiology, Warsaw, PolandMedical University of Bialystok;University of Eastern Finland;Amsterdam UMC, location VUmcNot yet recruiting18 Years70 YearsAll250Phase 3Poland
11EUCTR2021-003536-92-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
12EUCTR2021-003536-92-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
13EUCTR2021-003536-92-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
14EUCTR2021-006953-77-DK
(EUCTR)
11/04/202231/01/2022The effect of Bisoprolol and Verapamil in non-obstructive hypertrophic cardiomyopathyTreatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy - TEMPO II Non-obstructive Hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10007636;Term: Cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 20.0;Classification code 10049813;Term: Non-obstructive cardiomyopathy;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10061029;Term: Cardiomyopathy primary;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Bisoprolol
INN or Proposed INN: BISOPROLOL
Trade Name: Isoptin
INN or Proposed INN: VERAPAMIL HYDROCHLORIDE
Aarhus University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
140Phase 2Denmark
15EUCTR2021-003536-92-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
16NCT05186818
(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
17NCT05174416
(ClinicalTrials.gov)
January 4, 202213/12/2021A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCMA Phase III, Randomized, Double-blinded, Placebo-controlled Clinical Study With A Long-term Extension to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyObstructive Hypertrophic CardiomyopathyDrug: Mavacamten;Drug: PlaceboLianBio LLCNULLActive, not recruiting18 Years99 YearsAll81Phase 3China
18EUCTR2020-003571-17-IT
(EUCTR)
30/11/202102/09/2021An Open-Label Study of CK­3773274 for Patients with Symptomatic Hypertrophic Cardiomyopathy (HCM) and Left Ventricular Outflow Tract ObstructionAn 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Spain;Italy
19NCT04905173
(ClinicalTrials.gov)
November 202123/5/2021Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic CardiomyopathyComparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy;Hypertrophic Obstructive Cardiomyopathy;Cardiomyopathy, HypertrophicOther: Squat-to-stand maneuver;Drug: Amyl nitrite inhalation;Other: ValsalvaMayo ClinicNULLNot yet recruiting18 YearsN/AAll200N/AUnited States
20NCT05073094
(ClinicalTrials.gov)
October 6, 202119/5/2021Esmolol for Myocardial Protection in Hypertrophic Obstructive CardiomyopathyMyocardial Protection With Esmolol in Patients With Hypertrophic Obstructive Cardiomyopathy Undergoing Surgery Under Cardiopulmonary BypassHypertrophic Obstructive CardiomyopathyDrug: Esmolol;Drug: PlaceboMeshalkin Research Institute of Pathology of CirculationNULLRecruiting18 YearsN/AAll80Phase 4Russian Federation
21EUCTR2020-003571-17-ES
(EUCTR)
11/08/202114/07/2021This 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
54Phase 2United States;Spain;Italy
22ChiCTR2100048388
2021-07-012021-07-06The prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathyThe prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathy: a prospective study based on 18FAl-NOTA-FAPI-04 imaging hypertrophic cardiomyopathyGold Standard:Clinical outcome;Index test:18FAl-NOTA-FAPI imaging quantitatively detect myocardial fibrosis;Beijing Chaoyang Hospital, Capital Medical UniversityNULLPending14BothTarget condition:100;Difficult condition:0China
23NCT04826185
(ClinicalTrials.gov)
June 14, 202118/3/2021A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy TrialA Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic CardiomyopathyNon-obstructive Hypertrophic CardiomyopathyDrug: IMB-1018972;Drug: PlaceboImbria Pharmaceuticals, Inc.NULLRecruiting18 Years80 YearsAll60Phase 2United States;United Kingdom
24NCT04848506
(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
25NCT04783766
(ClinicalTrials.gov)
April 10, 20213/3/2021Safety, Tolerability and Pharmacokinetics Study of CK-3773274A Phase 1, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of CK-3773274 in Healthy Chinese SubjectsObstructive Hypertrophic Cardiomyopathy;Healthy Adult SubjectsDrug: CK-3773274;Drug: PlaceboJi Xing Pharmaceuticals (Shanghai) Co., Ltd.CytokineticsCompleted18 Years45 YearsAll28Phase 1China
26ChiCTR2000041243
2021-01-012020-12-22A study on the prognosis of hypertrophic cardiomyopathy in Chinese childrenClinical Characteristics and Outcomes of Hypertrophic Cardiomyopathy in Children: a Multicenter Retrospective Cohort Study in China Hypertrophic cardiomyopathySarcomeric HCM, RAS syndrome, IEM, and NMD:Nil;Shanghai Children's Medical Center affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting018BothSarcomeric HCM, RAS syndrome, IEM, and NMD:500;China
27ChiCTR2000041464
2021-01-012020-12-26The efficacy after alcohol septal ablation in mildly symptomatic patients with hypertrophic obstructive cardiomyopathy: a retrospective study based on medical recordsThe efficacy after alcohol septal ablation in mildly symptomatic patients with hypertrophic obstructive cardiomyopathy hypertrophic obstructive cardiomyopathyalcohol septal ablation group vs medical treatment group :Nil;Beijing Anzhen Hospital, Capital Medical UniversityNULLRecruiting1880Bothalcohol septal ablation group vs medical treatment group :200;China
28NCT04426578
(ClinicalTrials.gov)
December 1, 202014/5/2020Role of Perhexiline in Hypertrophic CardiomyopathyRandomised Controlled Trial of pErhexiline on regreSsion Of Left Ventricular hypErtrophy (LVH) in Patients With Symptomatic Hypertrophic CardioMyopathy (RESOLVE-HCM)Hypertrophic CardiomyopathyDrug: Perhexiline;Other: PlaceboFlinders UniversityNULLRecruiting18 YearsN/AAll60Phase 2Australia
29NCT04706429
(ClinicalTrials.gov)
December 1, 202011/1/2021The Efficacy and Mechanism of Trientine in Patients With Hypertrophic CardiomyopathyA Randomised, Double-blind, Placebo-controlled, Phase 2 Evaluation of the Efficacy and Mechanism of Trientine in Patients With Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: Trientine;Drug: PlaceboManchester University NHS Foundation TrustNational Institute for Health Research, United Kingdom;University of Manchester;University of Liverpool;Univar BV;University of OxfordRecruiting18 Years70 YearsAll172Phase 2United Kingdom
30NCT04418297
(ClinicalTrials.gov)
October 23, 202028/5/2020A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic CardiomyopathyA Randomized, Double-Blind, Placebo-Controlled, Sequential, Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CT-G20 in Subjects With Obstructive Hypertrophic CardiomyopathyCardiomyopathy, Hypertrophic ObstructiveDrug: CT-G20;Drug: PlaceboCelltrionNULLTerminated18 Years70 YearsAll23Phase 1United States;Korea, Republic of;Poland
31EUCTR2020-002242-17-GB
(EUCTR)
30/07/202003/06/2020A trial of trientine in patients with hypertrophic cardiomyopathyA randomised, double-blind, placebo-controlled, phase 2 evaluation of the efficacy and mechanism of trientine in patients with hypertrophic cardiomyopathy. - TEMPEST 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]
Trade Name: Cufence
Product Name: Cufence
INN or Proposed INN: Trientine
Other descriptive name: Triethylinetetramine dihydrochloride
Product Name: Placebo
Manchester University NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
172Phase 2United Kingdom
32ChiCTR2000033626
2020-06-012020-06-07Endocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive CardiomyopathyEndocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: a Randomized, Controlled, Open-Label Non-Inferiority Study Hypertrophic Obstructive Cardiomyopathydiofrequency ablation:radiofrequency ablation;Alcohol Ablation:Alcohol Septal Ablation;Sir Run Run Shaw Hospital, Zhejiang University School of MedicineNULLRecruiting1875Bothdiofrequency ablation:40;Alcohol Ablation:40;China
33EUCTR2019-002785-12-ES
(EUCTR)
25/05/202020/12/2019Pharmacokinetic 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Spain;Netherlands;United Kingdom;Italy
34EUCTR2019-002785-12-GB
(EUCTR)
08/05/202031/12/2019Pharmacokinetic 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Spain;Netherlands;Italy;United Kingdom
35EUCTR2019-003098-24-GB
(EUCTR)
30/04/202021/02/2020Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
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]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
36EUCTR2019-003098-24-GR
(EUCTR)
16/04/202013/04/2020Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
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]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
37EUCTR2019-003098-24-FI
(EUCTR)
15/04/202002/03/2020Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
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]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
38EUCTR2019-002785-12-IT
(EUCTR)
31/03/202004/02/2021Pharmacokinetic 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Spain;Netherlands;United Kingdom;Italy
39NCT04133532
(ClinicalTrials.gov)
March 5, 202016/10/2019Effect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic CardiomyopathyEffect of Metoprolol in Post Alcohol Septal Ablation Patients With Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: MetoprololUniversity Hospital, MotolNULLRecruiting18 Years75 YearsAll50Phase 4Czechia
40EUCTR2019-003098-24-ES
(EUCTR)
19/02/202002/12/2019Study of efficacy of oral sacubitril/valsartan adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
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]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2Greece;United States;Finland;Korea, Republic of;United Kingdom;Germany;Spain
41NCT04219826
(ClinicalTrials.gov)
January 10, 20203/1/2020REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in HCMA 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 CardiomyopathyHypertrophic Cardiomyopathy (HCM)Drug: CK-3773274 (5 - 15 mg);Drug: CK-3773274 (10 - 30 mg);Drug: Placebo for CK-3773274CytokineticsNULLActive, not recruiting18 Years85 YearsAll95Phase 2United States;Italy;Netherlands;Spain
42NCT04164732
(ClinicalTrials.gov)
January 8, 202013/11/2019Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic CardiomyopathyA Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)Cardiomyopathy, HypertrophicDrug: LCZ696;Drug: PlaceboNovartis PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll45Phase 2United States;Germany;Greece;Korea, Republic of;Spain;United Kingdom;Finland
43EUCTR2019-003098-24-DE
(EUCTR)
18/12/201905/11/2019Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
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]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
44EUCTR2018-004039-64-GB
(EUCTR)
14/11/201924/04/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
45NCT04129905
(ClinicalTrials.gov)
October 22, 201912/6/2019Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic CardiomyopathiesAssessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic CardiomyopathiesHypertrophic Cardiomyopathy;Endothelial DysfunctionBiological: BNP blood sample test;Diagnostic Test: Electrocardiogram;Diagnostic Test: Holter ECG;Diagnostic Test: Echocardiography;Diagnostic Test: Air venous plethysmography;Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD;Biological: Endothelial function biomarkersUniversity Hospital, BordeauxFédération Française de Cardiologie;Fondation Bordeaux Université;Amicus TherapeuticsCompleted18 YearsN/AAll40N/AFrance
46EUCTR2018-004039-64-NL
(EUCTR)
09/10/201904/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany
47EUCTR2018-004039-64-DK
(EUCTR)
30/09/201913/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
48JPRN-JapicCTI-194910
18/9/201908/08/2019Phase II clinical study of TY-0305 in symptomatic patients with hypertrophic obstructive cardiomyopathy -A pilot study-Phase II clinical study of TY-0305 in symptomatic patients with hypertrophic obstructive cardiomyopathy -A pilot study- Symptomatic hypertrophic obstructive cardiomyopathyIntervention name : TY-0305
INN of the intervention : Cibenzoline
Dosage And administration of the intervention : Two tablets orally of TY-0305 50mg twice or three times daily
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
TOA EIYO LTD.NULLrecruiting2075BOTH10Phase 2Japan
49EUCTR2018-004039-64-PL
(EUCTR)
26/08/201910/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Poland;Belgium;Denmark;Germany;Netherlands
50EUCTR2018-004039-64-DE
(EUCTR)
15/08/201912/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Czechia;United Kingdom;Portugal;Spain;Netherlands;Belgium;Poland;Denmark;Italy;Israel;France;Germany
51EUCTR2018-004039-64-ES
(EUCTR)
07/08/201902/09/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
52EUCTR2018-004039-64-BE
(EUCTR)
01/08/201906/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany
53EUCTR2018-004039-64-PT
(EUCTR)
29/07/201908/05/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
54EUCTR2018-004039-64-IT
(EUCTR)
08/07/201928/12/2020A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy.
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: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MYOKARDIA, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
55NCT03832660
(ClinicalTrials.gov)
May 3, 20191/2/2019Sacubitril/Valsartan vs Lifestyle in Hypertrophic CardiomyopathyClinical and Genetic Determinants of Disease Progression and Response to Sacubitril/Valsartan vs Lifestyle (Physical Activity and Dietary Nitrate) in Patients With Hypertrophic CardiomyopathyHypertrophic CardiomyopathyBehavioral: Lifestyle;Drug: Sacubitril/ValsartanNewcastle UniversityAzienda Ospedaliero-Universitaria Careggi;University Hospital Regensburg;Institute for Cardiovascular Diseases of Vojvodina;University of BelgradeCompleted18 Years70 YearsAll168Phase 2Germany;Italy;Serbia;United Kingdom
56NCT05366101
(ClinicalTrials.gov)
April 1, 20191/2/2019Lifestyle and Pharmacological Interventions in Hypertrophic CardiomyopathyClinical and Genetic Determinants of Disease Progression and Response to Lifestyle and Pharmacological Interventions in Patients With Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: Sacubitril/Valsartan;Behavioral: LifestyleNewcastle-upon-Tyne Hospitals NHS TrustUniversity Hospital Regensburg;Assistance Publique - Hôpitaux de Paris;Azienda Ospedaliero-Universitaria Careggi;Institute for Cardiovascular Diseases of VojvodinaCompleted18 Years70 YearsAll168Phase 2/Phase 3United Kingdom
57ChiCTR1900021706
2019-03-102019-03-05MicroRNA is involved in the mechanism of myocardial fibrosis in hypertrophic cardiomyopathyHypertrophic cardiomyopathy myocardial fibrosis Hypertrophic obstructive myocardiumHOCM:NO;West China Hospital, Sichuan UniversityNULLPending1870BothHOCM:40;N/AChina
58EUCTR2018-000029-29-NL
(EUCTR)
11/12/201811/12/2018Extra energy for hearts with a genetic defect: ENERGY trialExtra energy for hearts with a genetic defect: ENERGY trial - ENERGY Hypertrophic cardiomyopathy;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Vastarel
Product Name: Vastarel
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Netherlands
59EUCTR2017-002530-23-NL
(EUCTR)
10/12/201809/08/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany
60NCT03767855
(ClinicalTrials.gov)
December 4, 20183/12/2018A Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult SubjectsA Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of CK-3773274 in Healthy Adult SubjectsSymptomatic Obstructive Hypertrophic Cardiomyopathy;Healthy SubjectsDrug: CK-3773274 - Granules in Capsule;Drug: Placebo - Granules in Capsule;Drug: CK-3773274 - TabletsCytokineticsNULLCompleted18 Years55 YearsAll114Phase 1United States
61EUCTR2017-002530-23-DK
(EUCTR)
19/11/201824/09/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
62EUCTR2017-002530-23-PL
(EUCTR)
31/10/201814/08/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
63EUCTR2017-002530-23-CZ
(EUCTR)
25/10/201827/06/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
64EUCTR2017-002530-23-GB
(EUCTR)
22/10/201808/05/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
65EUCTR2017-002530-23-BE
(EUCTR)
22/10/201806/07/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
66ChiCTR-IIR-17013661
2018-10-102017-12-03Effect of beta-blockers combined with angiotensin II receptor blockers in regression of cardiac hypertrophy in patients with hypertrophic cardiomyopathy: A multicenter randomized, controlled clinical trialEffect of beta-blockers combined with angiotensin II receptor blockers in regression of cardiac hypertrophy in patients with hypertrophic cardiomyopathy: A multicenter randomized, controlled clinical trial Hypertrophic cardiomyopathyExperimental group:Metoprolol Succinate Sustained-release Tablets combined with candesartan treatment;Control group:Metoprolol Succinate Sustained-release Tablets monotherapy;The First Affiliated Hospital, Sun Yat-sen UniversityNULLRecruiting1865BothExperimental group:130;Control group:130;4 (Phase 4 study)China
67NCT03723655
(ClinicalTrials.gov)
October 5, 201824/10/2018A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCMA Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)Hypertrophic Cardiomyopathy;Obstructive Hypertrophic Cardiomyopathy;Non-obstructive Hypertrophic CardiomyopathyDrug: mavacamtenBristol-Myers SquibbNULLActive, not recruiting18 YearsN/AAll282Phase 2/Phase 3United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
68EUCTR2017-002530-23-DE
(EUCTR)
04/10/201803/05/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
69EUCTR2017-002530-23-ES
(EUCTR)
19/09/201812/06/2018A study to evaluate the safety and benefit of Mavacamten (MYK-461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
70EUCTR2017-002530-23-PT
(EUCTR)
17/09/201821/05/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
71EUCTR2017-002530-23-FR
(EUCTR)
11/09/201831/01/2019A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
72EUCTR2017-002530-23-IT
(EUCTR)
11/09/201810/11/2020A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
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: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
MYOKARDIA, INC.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
73NCT03043209
(ClinicalTrials.gov)
August 30, 20182/2/2017Genomic Sequencing in Patients With HCM Undergoing Septal MyectomyGenomic Sequencing in Patients With Hypertrophic Cardiomyopathy Undergoing Septal MyectomyHypertrophic Cardiomyopathy;Genetic Disease;Gene Product Sequence VariationGenetic: Genomic sequencingThe Cleveland ClinicNULLCompleted18 Years100 YearsAll25United States
74NCT03470545
(ClinicalTrials.gov)
May 29, 201812/3/2018Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyA Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyObstructive Hypertrophic CardiomyopathyDrug: mavacamten;Drug: PlaceboMyoKardia, Inc.NULLCompleted18 YearsN/AAll251Phase 3United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
75NCT02948998
(ClinicalTrials.gov)
May 14, 201827/10/2016Evaluating the Effect of Spironolactone on Hypertrophic CardiomyopathyEvaluating the Effect of Spironolactone on Hypertrophic Cardiomyopathy-- a Multicenter Randomized Control TrialHypertrophic Cardiomyopathy;FibrosisDrug: SpironolactoneXinhua Hospital, Shanghai Jiao Tong University School of MedicineRuijin Hospital;RenJi Hospital;Shanghai Jiao Tong University Affiliated Sixth People's HospitalUnknown status18 Years75 YearsAll260Phase 4China
76NCT03532802
(ClinicalTrials.gov)
May 1, 201819/4/2018The Effect of Metoprolol in Patients With Hypertrophic Obstructive Cardiomyopathy.The Effect of Metoprolol on Myocardial Function, Perfusion, Hemodynamics and Heart Failure Symptoms in Patients With Hypertrophic Obstructive Cardiomyopathy.Hypertrophic CardiomyopathyDrug: Metoprolol Succinate;Drug: Placebo oral capsuleSteen Hvitfeldt PoulsenNULLCompleted18 YearsN/AAll30Phase 2Denmark
77NCT03057002
(ClinicalTrials.gov)
May 1, 201810/1/2017UTSW HP [13-C] Pyruvate Injection in HCMDetection of Regional Myocardial Metabolic Changes in Patients With Hypertrophic Cardiomyopathy Using Hyperpolarized Carbon 13 Magnetic Resonance Spectroscopic Imaging (MRSI)Cardiomyopathy, HypertrophicDrug: Hyperpolarized 13C-PyruvateUniversity of Texas Southwestern Medical CenterNULLSuspended18 Years60 YearsAll10United States
78NCT03496168
(ClinicalTrials.gov)
April 26, 20185/4/2018Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEERAn Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)Hypertrophic CardiomyopathyDrug: mavacamtenBristol-Myers SquibbNULLActive, not recruiting18 YearsN/AAll13Phase 2United States
79NCT03442764
(ClinicalTrials.gov)
March 30, 20189/2/2018A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)A Randomized, Double-blind, Placebo-controlled, Concentration-guided, Exploratory Study of Mavacameten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) and Preserved Left Ventricular Ejection FractionNon-obstructive Hypertrophic CardiomyopathyDrug: mavacamten;Drug: PlaceboMyoKardia, Inc.NULLCompleted18 YearsN/AAll59Phase 2United States
80EUCTR2017-004478-32-DK
(EUCTR)
10/01/201814/12/2017The effect of metoprolol in hypertrophic obstructive cardiomyopathyThe effect of metoprolol on myocardial function, hemodynamics and heart failure symptoms in patients with hypertrophic obstructive cardiomyopathy - TEMPO Hypertrophic obstructive cardiomyopathy
MedDRA version: 20.0;Level: LLT;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Metoprololsuccinat
INN or Proposed INN: metoprololsuccinat
Other descriptive name: METOPROLOL SUCCINATE
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Denmark
81NCT03251287
(ClinicalTrials.gov)
November 201711/8/2017Nitrite in Hypertrophic Cardiomyopathy (HCM) StudyMechanistic Study of the Effect of Inorganic Sodium Nitrate on Cardiac and Skeletal Muscle Metabolic Efficiency in Patients With Hypertrophic CardiomyopathyCardiomyopathy, HypertrophicDrug: Sodium Nitrate;Drug: Placebo;Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy;Diagnostic Test: Exercise Stress Transthoracic EchocardiogramUniversity of East AngliaNorfolk and Norwich University Hospitals NHS Foundation Trust;British Medical Research CouncilRecruiting18 Years80 YearsAll18Phase 1United Kingdom
82NCT03249272
(ClinicalTrials.gov)
September 5, 20178/8/2017Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow ReserveMicrovascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow ReserveHypertrophic Cardiomyopathy;Non-ischemic Dilated Cardiomyopathy;Microvascular Ischaemia of MyocardiumDrug: Regadenoson;Drug: AdenosineDuke UniversityNULLTerminated18 YearsN/AAll31Phase 4United States
83EUCTR2015-004317-24-IT
(EUCTR)
22/06/201709/09/2021A pilot-study to assess Coronary Flow reserve and post-vasodilation Myocardial Blood Flow , measured by PET with 13N-Ammonia, before and after a six-month long treatment with the ACE-Inhibitor Perindopril, in patients with moderate and high-risk Hypertrophic CardiomyopathyA pilot study to assess Coronary Flow Reserve and post-vasodilatatory Myocardial Blood Flow (post-Dipi gMBF), measured by 13N-NH3 PET/CT, before and after a six months-long treatment with the ACE-inhibitor Perindopril, in moderate and high-risk HCM patients”A multicentric, interventional, open label, perspective-design, single-arm, pilot” clinical Study. - CARAPaCe (CoronAry Reserve After Perindopril in hypertophic Cardiomyopathy) Hypertrophic Cardiomyopathy (primitive)
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]
Trade Name: PROCAPTAN - 10 MG COMPRESSE RIVESTITE CON FILM 60 COMPRESSE IN CONTENITORE PER COMPRESSE PP
Product Name: procaptan
INN or Proposed INN: PERINDOPRIL ARGININA
Other descriptive name: perindopril arginine
Trade Name: PROCAPTAN - 5 MG COMPRESSE RIVESTITE CON FILM 10 COMPRESSE IN CONTENITORE PER COMPRESSE PP
Product Name: procaptan
INN or Proposed INN: PERINDOPRIL ARGININA
Other descriptive name: perindopril arginine
AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
21Phase 2Italy
84EUCTR2015-004402-42-IT
(EUCTR)
06/10/201609/09/2021A pilot study assessing the effects of Ranolazine on small heart vessels dysfunction in patients with hypertrophic cardiomyopathyA pilot study assessing the effects of Ranolazine on coronary microvascular dysfunction in patients with hypertrophic cardiomyopathy - Ranolazine microvascular dysfunction HCM Hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.1;Level: LLT;Classification code 10020204;Term: HOCM Hypertrophic obstructive cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10020203;Term: HOCM;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: RANEXA - 750 MG - COMPRESSA A RILASCIO PROLUNGATO- USO ORALE - BLISTER (PVC/PVDC/ALLUMINIO) 60 COMPRESSE
Product Name: Ranolazina Ranexa
Product Code: [C01EB18]
OSPEDALE SAN RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Italy
85NCT03953989
(ClinicalTrials.gov)
October 201613/5/2019Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic CardiomyopathyA Pilot Study Assessing the Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic CardiomyopathyHCM - Hypertrophic Non-Obstructive CardiomyopathyDrug: Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in dieIRCCS San RaffaeleMenarini International Operations Luxembourg SACompleted18 Years80 YearsAll26Phase 2Italy
86NCT02862600
(ClinicalTrials.gov)
August 1, 20168/8/2016Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart FailureA Phase 2, Multi-Center, Open-Label, Ascending Dose Study on the Efficacy, Safety and Tolerability of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure With Preserved Left Ventricular FunctionCardiomyopathy, Hypertrophic;Cardiomyopathy, Hypertrophic, FamilialDrug: Perhexiline;Device: Use of bioanalytical assay to monitor plasma levels of perhexilineHeart Metabolics LimitedNULLTerminated18 YearsN/AAll35Phase 2United States
87NCT02842242
(ClinicalTrials.gov)
August 201620/7/2016A Phase 2 Open-label Pilot Study Evaluating MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract ObstructionA Phase 2 Open-label Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-461 in Subjects With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract ObstructionCardiomyopathy, Hypertrophic Obstructive;Left Ventricular Outflow Tract ObstructionDrug: MYK-461MyoKardia, Inc.NULLCompleted18 Years70 YearsAll21Phase 2United States
88NCT02674958
(ClinicalTrials.gov)
May 20166/1/2016Mobilization of Endothelial Progenitor Cells and AspirinMobilization of Endothelial Progenitor Cells Following Alcohol Septal Ablation in Hypertrophic Obstructive Cardiomyopathy: Randomized Controlled Trial of AspirinHypertrophic Obstructive CardiomyopathyDrug: AspirinOttawa Heart Institute Research CorporationNULLTerminated18 Years80 YearsAll6Phase 3Canada
89EUCTR2015-002283-16-DK
(EUCTR)
08/03/201616/12/2015An international study of the effect of Valsartan in hypertrophic cardiomyopathy.Phase II randomized, placebo-controlled, double blind clinical trial of valsartan for attenuating disease evolution in early sarcomeric HCM - VANISH Hypertrophic cardiomyopathy
MedDRA version: 19.0;Level: LLT;Classification code 10020204;Term: HOCM Hypertrophic obstructive cardiomyopathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Diovan 40 mg
INN or Proposed INN: VALSARTAN
Other descriptive name: Diovan
Trade Name: Diovan 80 mg
INN or Proposed INN: VALSARTAN
Other descriptive name: Diovan
Trade Name: Diovan 160 mg
INN or Proposed INN: VALSARTAN
National Heart, Lung, and Blood Institute / National Institutes of HealthNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Denmark
90EUCTR2015-002432-40-IT
(EUCTR)
03/03/201627/05/2021Safety and Efficacy of yIFN treatment in Friedreich ataxiaSafety and Efficacy of yIFN treatment in Friedreich ataxia - ¿IFN in Friedreich Ataxia FRDA is a progressive neurodegenerative disease inherited as recessive trait. It manifests itself usually in adolescence and affects various systems including the central and peripheral nervous system (balance, coordination, speech and sensitivity), the heart with hypertrophic cardiomyopathy, the bones with skeletal deformities (scoliosis, claw foot) and in some cases diabetes mellitus. The disease causes severe and progressive disability, significantly reducing the life expectancy of patients.
MedDRA version: 20.0;Level: PT;Classification code 10017374;Term: Friedreich's ataxia;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IMUKIN - 6 FLACONI 0.5 ML 100 MCG
Product Name: Imukin
ASSOCIAZIONE LA NOSTRA FAMIGLIA - SEZIONE SCIENTIFICA I.R.C.C.S. E.MEDEANULLNot RecruitingFemale: yes
Male: yes
12Phase 2Italy
91NCT02560467
(ClinicalTrials.gov)
December 1, 201522/9/2015Perfusion Imaging With Myocardial Contrast Echocardiography in HCMHypertrophic CardiomyopathyDrug: Echo and myocardial contrast echocardiography perfusion imagingOregon Health and Science UniversityNULLActive, not recruiting19 Years80 YearsAll10N/AUnited States
92EUCTR2015-003521-34-FR
(EUCTR)
09/10/201508/09/2015Hypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrineHypertrophic CARdiomyopathy symptom release by alpha stimulant MIDOdrine - Light-CARMIDO Hypertrophic cardiomyopathy;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Trade Name: Gutron 2,5mg
INN or Proposed INN: MIDODRINE HYDROCHLORIDE
Trade Name: Gutron 5mg
INN or Proposed INN: MIDODRINE HYDROCHLORIDE
CHU de BordeauxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
93NCT02590809
(ClinicalTrials.gov)
October 7, 201527/10/2015Hypertrophic Cardiomyopathy Symptom Release by BX1514MHypertrophic CardiomyopathyDrug: Treatment BX1514M;Drug: Placebo;Other: Walk distance test;Other: Exercise echocardiographyUniversity Hospital, BordeauxNULLCompleted18 Years80 YearsAll38Phase 2France
94NCT02431221
(ClinicalTrials.gov)
July 22, 201527/4/2015Efficacy, Safety, and Tolerability of Perhexiline in Subjects With Hypertrophic Cardiomyopathy and Heart FailureA Study on the Efficacy, Safety, and Tolerability of Perhexiline Maleate in Subjects With Hypertrophic Cardiomyopathy and Moderate-To-Severe Heart FailureHypertrophic CardiomyopathyDrug: Perhexiline;Drug: PlaceboHeart Metabolics LimitedNULLWithdrawn18 YearsN/AAll0Phase 3NULL
95EUCTR2013-004429-97-IT
(EUCTR)
15/05/201512/05/2015A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic CardiomyopathyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy - NA Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed)
MedDRA version: 18.0;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: GS-6615 3 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Code: GS-6615 6 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Israel;Netherlands;Germany;United Kingdom;Italy
96EUCTR2013-004429-97-NL
(EUCTR)
13/04/201517/12/2014A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic CardiomyopathyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed)
MedDRA version: 18.0;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: GS-6615 3 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Code: GS-6615 6 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Israel;Germany;Netherlands;Italy;United Kingdom
97EUCTR2013-004429-97-GB
(EUCTR)
24/03/201505/11/2014A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic CardiomyopathyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed)
MedDRA version: 19.0;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: GS-6615 3 mg White
Product Code: GS-6615 3 mg White
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Name: GS-6615 6 mg White
Product Code: GS-6615 6 mg White
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Name: GS-6615 3 mg Pink
Product Code: GS-6615 3 mg Pink
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4- (trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4- (trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
98NCT02291237
(ClinicalTrials.gov)
February 5, 201511/11/2014Effect of Eleclazine (GS-6615) on Exercise Capacity in Subjects With Symptomatic Hypertrophic CardiomyopathyStudy Title: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects With Symptomatic Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: Eleclazine;Drug: PlaceboGilead SciencesNULLTerminated18 Years65 YearsAll172Phase 2/Phase 3United States;Australia;France;Germany;Israel;Italy;Netherlands;United Kingdom
99NCT02329184
(ClinicalTrials.gov)
December 201419/12/2014Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461Safety, Tolerability, Preliminary Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of MYK-461 in Patient Volunteers With Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: MYK-461MyoKardia, Inc.NULLCompleted18 Years65 YearsBoth15Phase 1United States
100EUCTR2014-001577-13-GB
(EUCTR)
15/07/201404/06/2014Trientine in Hypertrophic CardiomyopathyCopper Chelation in Hypertrophic Cardiomyopathy: Open-label pilot study of Trientine in patients with hypertrophic cardiomyopathy - Copper (II) Chelation therapy in the treatment of HCM Hypertrophic Cardiomyopathy
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]
Trade Name: Trientine dihydrochloride
Product Name: Trientine dihydrochloride
INN or Proposed INN: Trientine Dihydrochloride
Manchester University NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
101NCT01912534
(ClinicalTrials.gov)
March 20145/6/2013Valsartan for Attenuating Disease Evolution In Early Sarcomeric HCMValsartan for Attenuating Disease Evolution In Early Sarcomeric HCMHypertrophic CardiomyopathyDrug: Valsartan;Drug: PlaceboHealthCore-NERINational Heart, Lung, and Blood Institute (NHLBI)Completed8 Years45 YearsAll211Phase 2United States;Canada
102NCT01904396
(ClinicalTrials.gov)
August 201315/7/2013Identification of Carnitine-Responsive CardiomyopathyIdentification of Carnitine-responsive Cardiomyopathy and Myopathy in Adult Patients With Dilated and/or Hypertrophic Cardiomyopathy and Limb Girdle Weakness.Carnitine DeficiencyDrug: CarnitineUniversity Health Network, TorontoThe Physicians' Services Incorporated FoundationNot yet recruiting18 YearsN/ABoth30Phase 4Canada
103NCT01721967
(ClinicalTrials.gov)
November 20122/11/2012Ranolazine for the Treatment of Chest Pain in HCM PatientsRanolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy InvestigationHypertrophic CardiomyopathyDrug: RanolazineDuke UniversityGilead SciencesCompleted18 YearsN/AAll14Phase 4United States
104EUCTR2011-004507-20-DE
(EUCTR)
02/07/201217/10/2011SHCMRANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS (RESTYLE- HCM STUDY) - RESTYLE- HCM STUDY symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 17.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ranexa
Product Code: Ranolazine 500 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 750 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 1000 mg PR tablets
INN or Proposed INN: RANOLAZINE
Menarini International Operations Luxembourg S.A.NULLNot RecruitingFemale: yes
Male: yes
100Spain;Germany;Italy
105NCT01696370
(ClinicalTrials.gov)
April 201227/9/2012Trimetazidine Therapy in Hypertrophic CardiomyopathyA Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: Trimetazidine;Other: Placebo capsuleUniversity College, LondonBritish Heart FoundationRecruiting18 YearsN/ABoth90Phase 2United Kingdom
106EUCTR2011-004507-20-IT
(EUCTR)
22/02/201208/03/2012SHMCRANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 14.1;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: RANEXA*60CPR 500MG R.P.
INN or Proposed INN: RANOLAZINE
Other descriptive name: NA
Trade Name: RANEXA*60CPR 750MG R.P.
INN or Proposed INN: RANOLAZINE
Other descriptive name: NA
Trade Name: RANEXA
INN or Proposed INN: RANOLAZINE
Other descriptive name: NA
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Germany;Italy
107NCT01556568
(ClinicalTrials.gov)
February 201215/3/2012Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyAn Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyCardiomegalyDrug: MEK162Array Biopharma, now a wholly owned subsidiary of PfizerNULLWithdrawn18 Years65 YearsAll0Phase 2United States;United Kingdom
108EUCTR2011-003392-10-GB
(EUCTR)
23/01/201224/08/2011A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy. Noonan syndrome hypertrophic cardiomyopathy
MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: MEK162Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22United Kingdom;United States
109EUCTR2011-004507-20-ES
(EUCTR)
19/01/201213/10/2011SHMCRANOLAZINE IN PATIENTS WITH SYMPTOMATICHYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDYASSESSING THE EFFECTS ON EXERCISE CAPACITY,DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 14.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ranexa
Product Code: Ranolazine 500 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 750 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 1000 mg PR tablets
INN or Proposed INN: RANOLAZINE
Menarini International Operations Luxembourg S.A.NULLNot RecruitingFemale: yes
Male: yes
100Spain;Germany;Italy
110NCT01537926
(ClinicalTrials.gov)
January 201215/2/2012Hypertrophic Regression With N-Acetylcysteine in HCMPilot Feasibility Study With N-acetylcystein (NAC) in Patients With HCM Caused by Sarcomere Proteins MutationsHypertrophic CardiomyopathyDrug: N-acetylcysteine;Drug: PlaceboThe University of Texas Health Science Center, HoustonNational Institutes of Health (NIH)Completed18 YearsN/AAll42Phase 1United States
111NCT01447654
(ClinicalTrials.gov)
November 20114/10/2011Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic CardiomyopathyINHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.Hypertrophic CardiomyopathyDrug: Losartan;Drug: PlaceboHenning BundgaardNULLCompleted18 YearsN/ABoth130Phase 2Denmark
112EUCTR2011-001191-19-DK
(EUCTR)
26/10/201112/09/2011Effects on the heart in patients with hypertophic cardiomyopathy when treated with losartan.Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy. Hypertrophic cardiomyopathy
MedDRA version: 14.0;Level: LLT;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Losartan Bluefish 50 mg
Product Name: Losartan
Hjertemedicinsk klinik B, 2142, RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
Denmark
113EUCTR2011-000038-12-GB
(EUCTR)
13/09/201117/08/2011Trimetazidine therapy in Hypertrophic CardiomyopathyA Phase 2b randomised, double blind, placebo-controlled trial of trimetazidine therapy in patients with non-obstructive hypertrophic cardiomyopathy. - Trimetazidine therapy in hypertrophic cardiomyopathy Hypertrophic cardiomyopathy (non-obstructive)
MedDRA version: 16.1;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Vastarel 20mg film coated tablets
Product Name: Trimetazidine Dihydrochloride 20mg
Product Code: not applicable
INN or Proposed INN: trimetazidine dihydrochloride
Other descriptive name: 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride
University College London (UCL)NULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
114NCT01375335
(ClinicalTrials.gov)
June 201114/6/2011The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve ReplacementThe Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve StenosisHeart FailureDrug: DobutamineUniversity of AarhusNULLSuspended19 Years90 YearsBoth10Phase 4Denmark
115NCT00821353
(ClinicalTrials.gov)
January 200911/1/2009Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic CardiomyopathySinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)Atrial Fibrillation;Hypertrophic CardiomyopathyProcedure: RF catheter ablation;Drug: Antiarrhythmic drugsInstitute of Cardiology, Warsaw, PolandNULLCompleted18 Years70 YearsBoth90Phase 3Poland
116NCT00879060
(ClinicalTrials.gov)
November 20078/4/2009Clinical and Therapeutic Implications of Fibrosis in Hypertrophic CardiomyopathyClinical and Therapeutic Implications of Fibrosis in HypertrophicMyocardial Fibrosis;Hypertrophic CardiomyopathyDrug: spironolactoneTufts Medical CenterNULLRecruiting18 Years70 YearsBoth95Phase 4United States
117NCT00317967
(ClinicalTrials.gov)
April 200724/4/2006Study to Determine if Atorvastatin Reduces Size and Stiffness of Muscle in the Left Ventricle of the HeartStatin Induced Regression of Cardiomyopathy Trial - SirCatHypertrophic CardiomyopathyDrug: Atorvastatin;Drug: PlaceboUniversity of CalgaryHeart and Stroke Foundation of CanadaCompleted18 YearsN/ABoth22Phase 3Canada
118NCT00430833
(ClinicalTrials.gov)
March 200731/1/2007CHANCE - Candesartan in Hypertrophic CardiomyopathyCandesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter StudyHypertrophic CardiomyopathyDrug: candesartanCharles University, Czech RepublicAstraZenecaActive, not recruiting18 YearsN/ABothPhase 2Czech Republic
119NCT01150461
(ClinicalTrials.gov)
February 200722/6/2010Effect of Losartan in Patients With Nonobstructive Hypertrophic CardiomyopathyEffect of Losartan in Patients With Nonobstructive Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: losartan;Drug: placeboMassachusetts General HospitalNULLCompleted18 YearsN/AAll20Phase 2United States
120NCT00500552
(ClinicalTrials.gov)
December 200610/7/2007Perhexiline Therapy in Patients With Hypertrophic CardiomyopathyMetabolic Alteration With Perhexiline Therapy in Patients With Hypertrophic Cardiomyopathy (METAL-HCM Study)Hypertrophic CardiomyopathyDrug: Perhexiline/PlaceboUniversity Hospital BirminghamBritish Heart Foundation;University College London Hospitals;University of OxfordCompleted18 Years80 YearsBoth44Phase 2United Kingdom
121NCT00319982
(ClinicalTrials.gov)
January 200627/4/2006Treatment of Preclinical Hypertrophic Cardiomyopathy With DiltiazemTreatment of Preclinical Hypertrophic Cardiomyopathy With DiltiazemHypertrophic CardiomyopathyDrug: Diltiazem;Drug: PlaceboBrigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI);Boston Children’s HospitalCompleted5 Years39 YearsAll39Phase 2/Phase 3United States
122EUCTR2005-000755-15-GB
(EUCTR)
25/10/200527/05/2005Perhexiline therapy in patients with Hypertrophic CardiomyopathyPerhexiline therapy in patients with Hypertrophic Cardiomyopathy Hypertrophic CardiomyopathyProduct Name: Pexsig
INN or Proposed INN: Perxexiline
University Hospital of Birmingham Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50United Kingdom
123NCT00011076
(ClinicalTrials.gov)
February 20019/2/2001Pirfenidone to Treat Hypertrophic CardiomyopathyDouble-Blind Placebo-Controlled Study of Pirfenidone, A Novel Anti-Fibrotic Drug in Symptomatic Patients With Hypertrophic Cardiomyopathy (HCM) Associated With Left Ventricular Diastolic FunctionHypertrophic CardiomyopathyDrug: PirfenidoneNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth50Phase 2United States
124NCT00001965
(ClinicalTrials.gov)
December 199918/1/2000Cyclosporine A to Treat Hypertrophic Cardiomyopathy (HCM)Double Blind Placebo Controlled Study of Cyclosporin A in Patients With Left Ventricular Hypertrophy Caused by Sarcomeric Gene MutationsCardiomyopathy, Hypertrophic;Heart HypertrophyDrug: Cyclosporine ANational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth32Phase 2United States
125NCT00001534
(ClinicalTrials.gov)
September 19963/11/1999Long Term Effects of Enalapril and Losartan on Genetic Heart DiseaseDouble-Blind, Placebo-Controlled Study of the Long Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Hypertrophy in Non-Obstructive HCMHypertrophic Cardiomyopathy;Left Ventricular Hypertrophy;Myocardial IschemiaDrug: LosartanNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth112N/AUnited States
126EUCTR2019-002785-12-NL
(EUCTR)
20/01/2020Pharmacokinetic 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United States;Spain;Netherlands;United Kingdom;Italy