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


臨床試験数 : 119 薬物数 : 163 - (DrugBank : 45) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 161

  
No.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1NCT05186818
(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
2NCT05174416
(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 LLCNULLRecruiting18 Years99 YearsAll81Phase 3China
3EUCTR2020-003571-17-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
4NCT04905173
(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
5NCT05135871
(ClinicalTrials.gov)
October 31, 202128/10/2021Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese SubjectsAn Open-Label, Parallel-Group, Single-Center Phase 1 Clinical Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Mavacamten in Healthy Adult Chinese SubjectsHypertrophic CardiomyopathyDrug: MavacamtenLianBio LLCNULLRecruiting18 Years60 YearsAll44Phase 1China
6NCT05073094
(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
7EUCTR2020-003571-17-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
8NCT05025644
(ClinicalTrials.gov)
August 202111/8/2021Quantitative 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
9ChiCTR2100048388
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
10NCT04684290
(ClinicalTrials.gov)
June 30, 202116/11/2020Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive CardiomyopathySurgical Septal Myectomy Versus Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive CardiomyopathyHypertrophic CardiomyopathyProcedure: Alcohol Septal Ablation;Procedure: Surgical Septal MyectomySt. Antonius HospitalErasmus Medical CenterRecruiting40 Years75 YearsAll100N/ANetherlands
11NCT04826185
(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 Years75 YearsAll60Phase 2United States;United Kingdom
12NCT04848506
(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 2United States;Italy;Spain
13NCT04783766
(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
14ChiCTR2000041464
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
15ChiCTR2000041243
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
16NCT04706429
(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
17NCT04426578
(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
18NCT04418297
(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: PlaceboCelltrionNULLRecruiting18 Years70 YearsAll24Phase 1United States;Korea, Republic of;Poland
19EUCTR2020-002242-17-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
20NCT04349072
(ClinicalTrials.gov)
June 26, 20207/4/2020A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction TherapyA Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction TherapyHOCM, Hypertrophic Obstructive CardiomyopathyDrug: Mavacamten;Drug: PlaceboMyoKardia, Inc.NULLActive, not recruiting18 YearsN/AAll100Phase 3United States
21ChiCTR2000033626
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
22EUCTR2019-002785-12-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
23EUCTR2019-002785-12-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
24EUCTR2019-003098-24-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
25EUCTR2019-003098-24-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
26EUCTR2019-003098-24-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
27EUCTR2019-002785-12-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
28NCT04133532
(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
29EUCTR2019-003098-24-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 finished Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
30NCT04219826
(ClinicalTrials.gov)
January 10, 20203/1/2020REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in Obstructive Outflow Disease 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 Cardiomyopathy and Left Ventricular Outflow Tract ObstructionObstructive Hypertrophic CardiomyopathyDrug: CK-3773274 (5 - 15 mg);Drug: CK-3773274 (10 - 30 mg);Drug: Placebo for CK-3773274CytokineticsNULLRecruiting18 Years85 YearsAll48Phase 2United States;Italy;Netherlands;Spain
31NCT04164732
(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 PharmaceuticalsNULLRecruiting18 YearsN/AAll44Phase 2United States;Finland;Germany;Greece;Korea, Republic of;Spain;United Kingdom
32EUCTR2019-003098-24-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
33EUCTR2018-004039-64-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
34NCT04129905
(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
35EUCTR2018-004039-64-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
36EUCTR2018-004039-64-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
37JPRN-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
38EUCTR2018-004039-64-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
39EUCTR2018-004039-64-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;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
40EUCTR2018-004039-64-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
41EUCTR2018-004039-64-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;Germany;Netherlands
42EUCTR2018-004039-64-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
43EUCTR2018-004039-64-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
44NCT04066777
(ClinicalTrials.gov)
May 29, 201922/8/2019The Effect of TASH in Patients With HOCMThe Effect of Alcohol Septal Ablation Theraphy on Left Ventricular Function and Invasive Hemodynamics at Rest and During Exercise in Patients With Hypertrophic Obstructive CardiomyopathyHypertrophic Obstructive CardiomyopathyProcedure: alcohol septal ablationSteen Hvitfeldt PoulsenNULLRecruiting18 YearsN/AAll24N/ADenmark
45NCT03832660
(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 BelgradeRecruiting18 Years70 YearsAll240Phase 2Germany;Italy;Serbia;United Kingdom
46ChiCTR1900021706
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
47EUCTR2018-000029-29-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
48EUCTR2017-002530-23-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
49NCT03767855
(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
50EUCTR2017-002530-23-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
51EUCTR2017-002530-23-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
52EUCTR2017-002530-23-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
53EUCTR2017-002530-23-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
54EUCTR2017-002530-23-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
55ChiCTR-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
56NCT03723655
(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: mavacamtenMyoKardia, Inc.NULLEnrolling by invitation18 YearsN/AAll310Phase 2/Phase 3United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
57EUCTR2017-002530-23-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
58EUCTR2017-002530-23-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
59EUCTR2017-002530-23-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
60EUCTR2017-002530-23-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
61EUCTR2017-002530-23-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
62NCT03607669
(ClinicalTrials.gov)
June 1, 201820/7/2018Manganese-Enhanced Magnetic Resonance Imaging of the MyocardiumManganese-Enhanced Magnetic Resonance Imaging: Applications in CardiomyopathyIschemic Cardiomyopathy;Dilated Cardiomyopathy;Hypertrophic CardiomyopathyOther: Mangafodipir trisodiumUniversity of EdinburghNULLUnknown status18 Years65 YearsAll90United Kingdom
63NCT03470545
(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
64NCT02948998
(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
65NCT03532802
(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
66NCT03057002
(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
67NCT03496168
(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: mavacamtenMyoKardia, Inc.NULLActive, not recruiting18 YearsN/AAll12Phase 2United States
68NCT03442764
(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
69EUCTR2017-004478-32-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
70NCT03251287
(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
71NCT03249272
(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
72NCT03259113
(ClinicalTrials.gov)
August 16, 201719/8/2017Insertable Cardiac Monitors in Hypertrophic CardiomyopathyEvaLuation Using Cardiac Insertable Devices And TelephonE in Hypertrophic CardioMyopathyHypertrophic CardiomyopathyDevice: Insertable cardiac monitorRegion GävleborgSt. Jude Medical;Norrlands University HospitalRecruiting18 Years65 YearsAll30N/ASweden
73EUCTR2015-004317-24-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
74NCT03049995
(ClinicalTrials.gov)
November 20162/2/2017Stress Echo 2020 - The International Stress Echo StudyThe International Stress Echo Study in Ischemic and Non-ischemic Heart DiseaseCoronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial HypertensionProcedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SEFatebenefratelli HospitalInstitute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre;University of Parma;Hospital Clinics, Trieste, Italy;Federal University of Rio Grande do Sul;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic Tokuda Hospital;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian Federation;Instituto Nacional de Cardiología Mexico City, Mexico;Hamad Medical Corporation, Heart Hospital -Doha-QatarRecruiting18 Years85 YearsAll300Italy
75EUCTR2015-004402-42-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
76NCT03953989
(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
77NCT02862600
(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
78NCT02842242
(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
79NCT02674958
(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 CorporationNULLRecruiting18 Years80 YearsAll20Phase 3Canada
80EUCTR2015-002283-16-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
81EUCTR2015-002432-40-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
82NCT02560467
(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
83EUCTR2015-003521-34-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
84NCT02590809
(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
85NCT02431221
(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
86NCT02559726
(ClinicalTrials.gov)
June 22, 201526/6/2015Hyper-synchronicity in Hypertrophic Cardiomyopathy (HCM) : Description, Mechanism and Origin With a Multi-imaging Approach to Predict Dual Chamber Pacing ResponseIdentification and Quantification of a Mechanical Hyper-synchronicity State in Hypertrophic Cardiomyopathy (HCM) With Left Outflow-tract Obstruction and Description of Its Electrical and Electro-mechanical Characteristics Thanks to an Innovative Multi-imaging Approach to Predict a Positive Response to Dual Chamber Pacing. The Hsync Study.Hypertrophic Cardiomyopathy;Mechanical Hyper-synchronicityProcedure: Echocardiography (TEE);Device: Magnetic resonance imaging (MRI) with gadolinium enhancement;Device: Magnetic resonance imaging (MRI) without gadolinium enhancement;Procedure: 3D electrocardiographic mapping (ECM)University Hospital, BordeauxNULLCompleted18 YearsN/AAll60N/AFrance
87EUCTR2013-004429-97-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
88EUCTR2013-004429-97-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
89EUCTR2013-004429-97-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
90NCT02291237
(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
91NCT02329184
(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
92EUCTR2014-001577-13-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
93NCT01912534
(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
94NCT01904396
(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
95NCT01721967
(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
96EUCTR2011-004507-20-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
97NCT01696370
(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
98EUCTR2011-004507-20-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
99NCT01556568
(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
100EUCTR2011-003392-10-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
101EUCTR2011-004507-20-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
102NCT01537926
(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
103NCT01447654
(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
104EUCTR2011-001191-19-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
105EUCTR2011-000038-12-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
106NCT01375335
(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
107NCT00821353
(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
108NCT00879060
(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
109NCT00317967
(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
110NCT00430833
(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
111NCT01150461
(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
112NCT00500552
(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
113NCT00319982
(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
114EUCTR2005-000755-15-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
115NCT00035386
(ClinicalTrials.gov)
April 20022/5/2002Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot StudyTrans-Right Ventricular Approach to Alcohol Septal Ablation in Obstructive Hypertrophic Cardiomyopathy: A Pilot Feasibility StudyHypertrophic CardiomyopathyProcedure: trans-right ventricular alcohol septal ablation (TRVASA)National Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth12Phase 2United States
116NCT00011076
(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
117NCT00001965
(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
118NCT00001534
(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
119EUCTR2019-002785-12-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;Italy;United Kingdom;Netherlands;Spain