58. 肥大型心筋症 [臨床試験数:92,薬物数:126(DrugBank:35),標的遺伝子数:40,標的パスウェイ数:141

Searched query = "Hypertrophic cardiomyopathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04418297October 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
2NCT04426578August 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 UniversityNULLNot yet recruiting18 YearsN/AAll60Phase 2NULL
3EUCTR2020-002242-17-GB30/07/202003/06/2020A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
4NCT04349072June 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.NULLRecruiting18 YearsN/AAll100Phase 3United States
5EUCTR2019-002785-12-ES25/05/202020/12/2019Pharmacokinetic 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-002785-12-GB08/05/202031/12/2019Pharmacokinetic 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
7EUCTR2019-003098-24-GB30/04/202021/02/2020Study 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
8EUCTR2019-003098-24-GR16/04/202013/04/2020Study 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
9EUCTR2019-003098-24-FI15/04/202002/03/2020Study 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
10NCT04133532March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-003098-24-ES19/02/202002/12/2019Study 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]
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
12NCT04219826January 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 YearsAll60Phase 2United States;Italy;Netherlands;Spain
13NCT04164732January 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
14EUCTR2019-003098-24-DE18/12/201905/11/2019Study 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
15EUCTR2018-004039-64-GB14/11/201924/04/2019A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT04129905October 21, 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 TherapeuticsNot yet recruiting18 YearsN/AAll40N/AFrance
17EUCTR2018-004039-64-NL09/10/201904/06/2019A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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;Netherlands;Germany
18EUCTR2018-004039-64-DK30/09/201913/06/2019A 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]
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
19EUCTR2018-004039-64-DE15/08/201912/06/2019A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
20EUCTR2018-004039-64-ES07/08/201902/09/2019A 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]
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noUnited States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2018-004039-64-BE01/08/201906/06/2019A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
22EUCTR2018-004039-64-PT29/07/201908/05/2019A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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 3Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
23EUCTR2018-004039-64-IT08/07/201928/12/2020A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
24NCT03832660May 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
25EUCTR2018-000029-29-NL11/12/201811/12/2018Extra 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]VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noNetherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2017-002530-23-NL10/12/201809/08/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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;Netherlands;Germany
27NCT03767855December 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
28EUCTR2017-002530-23-DK19/11/201824/09/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
29EUCTR2017-002530-23-PL31/10/201814/08/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
30EUCTR2017-002530-23-CZ25/10/201827/06/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2017-002530-23-BE22/10/201806/07/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
32EUCTR2017-002530-23-GB22/10/201808/05/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
33ChiCTR-IIR-170136612018-10-102017-12-03Effect 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
34NCT03723655October 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
35EUCTR2017-002530-23-DE04/10/201803/05/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2017-002530-23-ES19/09/201812/06/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
220Phase 3United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
37EUCTR2017-002530-23-PT17/09/201821/05/2018A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
38EUCTR2017-002530-23-FR11/09/201831/01/2019A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
39EUCTR2017-002530-23-IT11/09/201810/11/2020A 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
40NCT03607669June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT03470545May 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
42NCT02948998May 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
43NCT03057002May 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
44NCT03532802May 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 PoulsenNULLRecruiting18 YearsN/AAll32Phase 2Denmark
45NCT03496168April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03442764March 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
47NCT03251287November 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
48NCT03249272September 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
49NCT03259113August 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
50NCT03049995November 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, Napoli, Italy;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre, Italy;University of Parma;Hospital Clinics, Trieste, Italy;Hospital de Clinicas de Porto Alegre - Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade,Serbia;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, University Hospital,Sofia,Bulgaria;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian FederationRecruiting18 Years85 YearsAll300N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03953989October 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
52NCT02862600August 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
53NCT02842242August 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
54EUCTR2015-002283-16-DK08/03/201616/12/2015An 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: 19.0Level: LLTClassification code 10020204Term: HOCM Hypertrophic obstructive cardiomyopathySystem 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
55NCT02560467December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
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PhaseCountries
56EUCTR2015-003521-34-FR09/10/201508/09/2015Hypertrophic 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
57NCT02590809October 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
58NCT02431221July 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
59NCT02559726June 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, BordeauxNULLRecruiting18 YearsN/ABoth60N/AFrance
60EUCTR2013-004429-97-IT15/05/201512/05/2015A 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: 18.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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Target_
size
PhaseCountries
61EUCTR2013-004429-97-NL13/04/201517/12/2014A 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: 18.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
62EUCTR2013-004429-97-GB24/03/201505/11/2014A 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: 19.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
63NCT02291237February 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
64NCT02329184December 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
65EUCTR2014-001577-13-GB15/07/201404/06/2014Trientine 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]
Manchester University NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): yesUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
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size
PhaseCountries
66NCT01912534March 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)Active, not recruiting8 Years45 YearsAll211Phase 2United States;Canada
67NCT01904396August 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
68NCT01721967November 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
69EUCTR2011-004507-20-DE02/07/201217/10/2011SHCMRANOLAZINE 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: 17.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
70NCT01696370April 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
71EUCTR2011-004507-20-IT22/02/201208/03/2012SHMCRANOLAZINE 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]
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noSpain;Germany;Italy
72NCT01556568February 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
73EUCTR2011-003392-10-GB23/01/201224/08/2011A 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: 14.1Level: PTClassification code 10029748Term: Noonan syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
74EUCTR2011-004507-20-ES19/01/201213/10/2011SHMCRANOLAZINE IN PATIENTS WITH SYMPTOMATICHYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDYASSESSING THE EFFECTS ON EXERCISE CAPACITY,DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 14.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
75NCT01537926January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
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agemin
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agemax
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size
PhaseCountries
76NCT01447654November 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
77EUCTR2011-001191-19-DK26/10/201112/09/2011Effects 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: 14.0Level: LLTClassification code 10020876Term: Hypertrophic obstructive cardiomyopathySystem 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
78EUCTR2011-000038-12-GB13/09/201117/08/2011Trimetazidine 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: 16.1Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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
79NCT01375335June 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
80NCT00821353January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
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Target_
size
PhaseCountries
81NCT00879060November 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
82NCT00317967April 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
83NCT00430833March 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
84NCT01150461February 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
85NCT00500552December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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Status
Inclusion_
agemin
Inclusion_
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PhaseCountries
86NCT00319982January 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
87EUCTR2005-000755-15-GB25/10/200527/05/2005Perhexiline 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
88NCT00035386April 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
89NCT00011076February 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
90NCT00001965December 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00001534September 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
92EUCTR2019-002785-12-NL20/01/2020Pharmacokinetic 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: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem 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