DDrare: Database of Drug Development for Rare Diseases

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.

Drug = (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE; 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride; Acetylcysteine; Adenosine; Air; Alcohol; Antiarrhythmic drugs; Atorvastatin; BNP; BNP blood sample test; Behavioral: Lifestyle; Bluefish; 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; 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; CK-3773274; CK-3773274 (10 - 30 mg); CK-3773274 (5 - 15 mg); CK-3773274 - Granules in Capsule; CK-3773274 - Tablets; CT-G20; Candesartan; Carnitine; Cufence; Cyclosporine; Cyclosporine A; Device: Insertable cardiac monitor; Device: Magnetic resonance imaging (MRI) with gadolinium enhancement; Device: Magnetic resonance imaging (MRI) without gadolinium enhancement; Device: Use of bioanalytical assay to monitor plasma levels of perhexiline; Diagnostic Test: Air venous plethysmography; Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram; Diagnostic Test: Exercise Stress Transthoracic Echocardiogram; Diagnostic Test: Holter ECG; Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy; Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD; Diltiazem; Diovan; Diovan 160 mg; Diovan 40 mg; Diovan 80 mg; Dobutamine; Echo and myocardial contrast echocardiography perfusion imaging; Eleclazine; Endothelial function biomarkers; Entresto; GS-6615 3 mg; GS-6615 3 mg Pink; GS-6615 3 mg White; GS-6615 6 mg; GS-6615 6 mg White; Gadolinium; Gradient; Gutron 2,5mg; Gutron 5mg; Hyperpolarized 13C-Pyruvate; LCZ696; LCZ696 100 mg; LCZ696 200 mg; LCZ696 50 mg; Losartan; Losartan Bluefish 50 mg; MAVACAMTEN; MEK162; MIDODRINE HYDROCHLORIDE; MONITOR; MYK-461; Mangafodipir; Mavacamten; Metoprolol; Metoprolol Succinate; Midodrine; N-acetylcysteine; Nitrate; Other: Exercise echocardiography; Other: Mangafodipir trisodium; Other: Walk distance test; Perhexiline; Perxexiline; Pexsig; Phosphorous; Piperazine; Pirfenidone; Procedure: 3D electrocardiographic mapping (ECM); Procedure: B-lines SE; Procedure: Coronary flow reserve SE; Procedure: Diastolic function SE; Procedure: Echocardiography (TEE); Procedure: Left ventricular contractile reserve SE; Procedure: Left ventricular outflow tract gradient SE; Procedure: Mitral regurgitation SE; Procedure: Pulmonary hemodynamics SE; Procedure: RF catheter ablation; Procedure: trans-right ventricular alcohol septal ablation (TRVASA); Pyrazole; RANEXA; RANEXA*60CPR 500MG R.P.; RANEXA*60CPR 750MG R.P.; RANOLAZINE; Ranexa; Ranolazine; Ranolazine 1000 mg PR tablets; Ranolazine 500 mg PR tablets; Ranolazine 750 mg PR tablets; Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die; Regadenoson; SACUBITRIL VALSARTAN; Sacubitril; Sacubitril/Valsartan; Sacubitril/valsartan; Sodium Nitrate; Sodium nitrate; Spironolactone; Treatment BX1514M; Trientine; Trientine Dihydrochloride; Trientine dihydrochloride; Triethylinetetramine dihydrochloride; Trimetazidine; Trimetazidine Dihydrochloride 20mg; Trimetazidine dihydrochloride; VALSARTAN; Valsartan; Vastarel; Vastarel 20mg film coated tablets; [MYK-461]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT04349072 (ClinicalTrials.gov)	June 26, 2020	7/4/2020	A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy	A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy	HOCM, Hypertrophic Obstructive Cardiomyopathy	Drug: Mavacamten;Drug: Placebo	MyoKardia, Inc.	NULL	Recruiting	18 Years	N/A	All	100	Phase 3	United States
2	EUCTR2018-004039-64-GB (EUCTR)	14/11/2019	24/04/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
3	EUCTR2018-004039-64-NL (EUCTR)	09/10/2019	04/06/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany
4	EUCTR2018-004039-64-DK (EUCTR)	30/09/2019	13/06/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
5	EUCTR2018-004039-64-DE (EUCTR)	15/08/2019	12/06/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-004039-64-ES (EUCTR)	07/08/2019	02/09/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
7	EUCTR2018-004039-64-BE (EUCTR)	01/08/2019	06/06/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	250	Phase 3	Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
8	EUCTR2018-004039-64-PT (EUCTR)	29/07/2019	08/05/2019	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
9	EUCTR2018-004039-64-IT (EUCTR)	08/07/2019	28/12/2020	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)	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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	280	Phase 3	United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
10	EUCTR2017-002530-23-NL (EUCTR)	10/12/2018	09/08/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2017-002530-23-DK (EUCTR)	19/11/2018	24/09/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
12	EUCTR2017-002530-23-PL (EUCTR)	31/10/2018	14/08/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
13	EUCTR2017-002530-23-CZ (EUCTR)	25/10/2018	27/06/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
14	EUCTR2017-002530-23-BE (EUCTR)	22/10/2018	06/07/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
15	EUCTR2017-002530-23-GB (EUCTR)	22/10/2018	08/05/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
16	NCT03723655 (ClinicalTrials.gov)	October 5, 2018	24/10/2018	A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM	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)	Hypertrophic Cardiomyopathy;Obstructive Hypertrophic Cardiomyopathy;Non-obstructive Hypertrophic Cardiomyopathy	Drug: mavacamten	MyoKardia, Inc.	NULL	Enrolling by invitation	18 Years	N/A	All	310	Phase 2;Phase 3	United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
17	EUCTR2017-002530-23-DE (EUCTR)	04/10/2018	03/05/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
18	EUCTR2017-002530-23-ES (EUCTR)	19/09/2018	12/06/2018	A study to evaluate the safety and benefit of Mavacamten (MYK-461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	220	Phase 3	United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
19	EUCTR2017-002530-23-PT (EUCTR)	17/09/2018	21/05/2018	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
20	EUCTR2017-002530-23-IT (EUCTR)	11/09/2018	10/11/2020	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
21	EUCTR2017-002530-23-FR (EUCTR)	11/09/2018	31/01/2019	A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle	A 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.	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 3	Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
22	NCT03470545 (ClinicalTrials.gov)	May 29, 2018	12/3/2018	Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy	A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy	Obstructive Hypertrophic Cardiomyopathy	Drug: mavacamten;Drug: Placebo	MyoKardia, Inc.	NULL	Completed	18 Years	N/A	All	251	Phase 3	United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
23	NCT03496168 (ClinicalTrials.gov)	April 26, 2018	5/4/2018	Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER	An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)	Hypertrophic Cardiomyopathy	Drug: mavacamten	MyoKardia, Inc.	NULL	Active, not recruiting	18 Years	N/A	All	12	Phase 2	United States
24	NCT03442764 (ClinicalTrials.gov)	March 30, 2018	9/2/2018	A 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 Fraction	Non-obstructive Hypertrophic Cardiomyopathy	Drug: mavacamten;Drug: Placebo	MyoKardia, Inc.	NULL	Completed	18 Years	N/A	All	59	Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT04349072
(ClinicalTrials.gov)

June 26, 2020

7/4/2020

A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction Therapy

HOCM, Hypertrophic Obstructive Cardiomyopathy

Drug: Mavacamten;Drug: Placebo

MyoKardia, Inc.

NULL

Recruiting

18 Years

N/A

All

100

Phase 3

United States

EUCTR2018-004039-64-GB
(EUCTR)

14/11/2019

24/04/2019

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)

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.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2018-004039-64-NL
(EUCTR)

09/10/2019

04/06/2019

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)

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.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 3

Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany

EUCTR2018-004039-64-DK
(EUCTR)

30/09/2019

13/06/2019

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)

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.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2018-004039-64-DE
(EUCTR)

15/08/2019

12/06/2019

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)

MyoKardia, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-004039-64-ES
(EUCTR)

07/08/2019

02/09/2019

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)

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.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2018-004039-64-BE
(EUCTR)

01/08/2019

06/06/2019

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)

MyoKardia, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

250

Phase 3

Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2018-004039-64-PT
(EUCTR)

29/07/2019

08/05/2019

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)

MyoKardia, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2018-004039-64-IT
(EUCTR)

08/07/2019

28/12/2020

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)

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.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

280

Phase 3

United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-NL
(EUCTR)

10/12/2018

09/08/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002530-23-DK
(EUCTR)

19/11/2018

24/09/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-PL
(EUCTR)

31/10/2018

14/08/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands

EUCTR2017-002530-23-CZ
(EUCTR)

25/10/2018

27/06/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-BE
(EUCTR)

22/10/2018

06/07/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-GB
(EUCTR)

22/10/2018

08/05/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT03723655
(ClinicalTrials.gov)

October 5, 2018

24/10/2018

A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

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)

Hypertrophic Cardiomyopathy;Obstructive Hypertrophic Cardiomyopathy;Non-obstructive Hypertrophic Cardiomyopathy

Drug: mavacamten

MyoKardia, Inc.

NULL

Enrolling by invitation

18 Years

N/A

All

310

Phase 2;Phase 3

United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom

EUCTR2017-002530-23-DE
(EUCTR)

04/10/2018

03/05/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-ES
(EUCTR)

19/09/2018

12/06/2018

A study to evaluate the safety and benefit of Mavacamten (MYK-461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

220

Phase 3

United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-PT
(EUCTR)

17/09/2018

21/05/2018

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

EUCTR2017-002530-23-IT
(EUCTR)

11/09/2018

10/11/2020

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

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.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2017-002530-23-FR
(EUCTR)

11/09/2018

31/01/2019

A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscle

A Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM

MyoKardia, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

220

Phase 3

Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands

NCT03470545
(ClinicalTrials.gov)

May 29, 2018

12/3/2018

Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

A Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy

Obstructive Hypertrophic Cardiomyopathy

Drug: mavacamten;Drug: Placebo

MyoKardia, Inc.

NULL

Completed

18 Years

N/A

All

251

Phase 3

United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom

NCT03496168
(ClinicalTrials.gov)

April 26, 2018

5/4/2018

Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEER

An Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)

Hypertrophic Cardiomyopathy

Drug: mavacamten

MyoKardia, Inc.

NULL

Active, not recruiting

18 Years

N/A

All

Phase 2

United States

NCT03442764
(ClinicalTrials.gov)

March 30, 2018

9/2/2018

A 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 Fraction

Non-obstructive Hypertrophic Cardiomyopathy

Drug: mavacamten;Drug: Placebo

MyoKardia, Inc.

NULL

Completed

18 Years

N/A

All

Phase 2

United States