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


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

  
27 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
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PhaseCountries
1NCT05174416
(ClinicalTrials.gov)
January 4, 202213/12/2021A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCMA Phase III, Randomized, Double-blinded, Placebo-controlled Clinical Study With A Long-term Extension to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyObstructive Hypertrophic CardiomyopathyDrug: Mavacamten;Drug: PlaceboLianBio LLCNULLRecruiting18 Years99 YearsAll81Phase 3China
2NCT05135871
(ClinicalTrials.gov)
October 31, 202128/10/2021Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese SubjectsAn Open-Label, Parallel-Group, Single-Center Phase 1 Clinical Study to Evaluate the Pharmacokinetics of a Single Oral Dose of Mavacamten in Healthy Adult Chinese SubjectsHypertrophic CardiomyopathyDrug: MavacamtenLianBio LLCNULLRecruiting18 Years60 YearsAll44Phase 1China
3NCT04349072
(ClinicalTrials.gov)
June 26, 20207/4/2020A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction TherapyA Randomized, Double-blind, Placebo-controlled Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Who Are Eligible for Septal Reduction TherapyHOCM, Hypertrophic Obstructive CardiomyopathyDrug: Mavacamten;Drug: PlaceboMyoKardia, Inc.NULLActive, not recruiting18 YearsN/AAll100Phase 3United States
4EUCTR2018-004039-64-GB
(EUCTR)
14/11/201924/04/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
5EUCTR2018-004039-64-NL
(EUCTR)
09/10/201904/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany
6EUCTR2018-004039-64-DK
(EUCTR)
30/09/201913/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
7EUCTR2018-004039-64-PL
(EUCTR)
26/08/201910/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Poland;Belgium;Denmark;Germany;Netherlands
8EUCTR2018-004039-64-DE
(EUCTR)
15/08/201912/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
9EUCTR2018-004039-64-ES
(EUCTR)
07/08/201902/09/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
10EUCTR2018-004039-64-BE
(EUCTR)
01/08/201906/06/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
11EUCTR2018-004039-64-PT
(EUCTR)
29/07/201908/05/2019A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
12EUCTR2018-004039-64-IT
(EUCTR)
08/07/201928/12/2020A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)A Long-term Safety Extension Study of Mavacamten (MYK-461) in Adults with Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE) - MAVA-LTE Hypertrophic Cardiomyopathy.
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: [MYK-461]
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MYOKARDIA, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands
13EUCTR2017-002530-23-NL
(EUCTR)
10/12/201809/08/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany
14EUCTR2017-002530-23-DK
(EUCTR)
19/11/201824/09/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
15EUCTR2017-002530-23-PL
(EUCTR)
31/10/201814/08/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Poland;Belgium;Denmark;Germany;Netherlands
16EUCTR2017-002530-23-CZ
(EUCTR)
25/10/201827/06/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
17EUCTR2017-002530-23-GB
(EUCTR)
22/10/201808/05/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
18EUCTR2017-002530-23-BE
(EUCTR)
22/10/201806/07/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
19NCT03723655
(ClinicalTrials.gov)
October 5, 201824/10/2018A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCMA Long-Term Safety Extension Study of Mavacamten (MYK-461) in Adults With Hypertrophic Cardiomyopathy Who Have Completed the MAVERICK-HCM (MYK-461-006) or EXPLORER-HCM (MYK-461-005) Trials (MAVA-LTE)Hypertrophic Cardiomyopathy;Obstructive Hypertrophic Cardiomyopathy;Non-obstructive Hypertrophic CardiomyopathyDrug: mavacamtenMyoKardia, Inc.NULLEnrolling by invitation18 YearsN/AAll310Phase 2/Phase 3United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
20EUCTR2017-002530-23-DE
(EUCTR)
04/10/201803/05/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
21EUCTR2017-002530-23-ES
(EUCTR)
19/09/201812/06/2018A study to evaluate the safety and benefit of Mavacamten (MYK-461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
22EUCTR2017-002530-23-PT
(EUCTR)
17/09/201821/05/2018A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
23EUCTR2017-002530-23-FR
(EUCTR)
11/09/201831/01/2019A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: NA
Other descriptive name: MAVACAMTEN
MyoKardia, Inc.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
24EUCTR2017-002530-23-IT
(EUCTR)
11/09/201810/11/2020A study to evaluate the safety and benefit of Mavacamten (MYK 461) in adults with an inherited heart disease causing thickening of the heart muscleA Randomized, Double blind, Placebo controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy - EXPLORER-HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
Product Name: Mavacamten
Product Code: MYK-461
INN or Proposed INN: Mavacamten
Other descriptive name: Mavacamten
MYOKARDIA, INC.NULLNot RecruitingFemale: yes
Male: yes
220Phase 3Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands
25NCT03470545
(ClinicalTrials.gov)
May 29, 201812/3/2018Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyA Randomized, Double Blind, Placebo Controlled Clinical Study to Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic CardiomyopathyObstructive Hypertrophic CardiomyopathyDrug: mavacamten;Drug: PlaceboMyoKardia, Inc.NULLCompleted18 YearsN/AAll251Phase 3United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom
26NCT03496168
(ClinicalTrials.gov)
April 26, 20185/4/2018Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in PIONEERAn Open-Label Extension Study of Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy Previously Enrolled in Study MYK-461-004 (PIONEER)Hypertrophic CardiomyopathyDrug: mavacamtenMyoKardia, Inc.NULLActive, not recruiting18 YearsN/AAll12Phase 2United States
27NCT03442764
(ClinicalTrials.gov)
March 30, 20189/2/2018A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM)A Randomized, Double-blind, Placebo-controlled, Concentration-guided, Exploratory Study of Mavacameten in Patients With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) and Preserved Left Ventricular Ejection FractionNon-obstructive Hypertrophic CardiomyopathyDrug: mavacamten;Drug: PlaceboMyoKardia, Inc.NULLCompleted18 YearsN/AAll59Phase 2United States