58. 肥大型心筋症 Hypertrophic cardiomyopathy Clinical trials / Disease details
臨床試験数 : 126 / 薬物数 : 135 - (DrugBank : 42) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 162
| No. | 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 | EUCTR2021-005329-26-ES (EUCTR) | 26/01/2023 | 01/11/2022 | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Cardiomyopathy | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Mavacamten in nonobstructive HCM | Symptomatic Nonobstructive Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10049813;Term: Non-obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN | Myokardia, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Denmark;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 2 | EUCTR2021-005329-26-FR (EUCTR) | 24/01/2023 | 07/10/2022 | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Cardiomyopathy | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults with Symptomatic Nonobstructive Hypertrophic Cardiomyopathy - Mavacamten in nonobstructive HCM | Symptomatic Nonobstructive Hypertrophic Cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10049813;Term: Non-obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN Product Name: Mavacamten Product Code: MYK-461 INN or Proposed INN: NA Other descriptive name: MAVACAMTEN | Myokardia, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Canada;Belgium;Brazil;Poland;Denmark;Australia;Norway;Germany;Netherlands;Japan;Korea, Republic of | ||
| 3 | NCT05582395 (ClinicalTrials.gov) | December 14, 2022 | 14/9/2022 | A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy | A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate Mavacamten in Adults With Symptomatic Non-obstructive Hypertrophic Cardiomyopathy | Cardiomyopathy, Hypertrophic | Drug: Mavacamten;Other: Placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 420 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Netherlands;Norway;Poland;Portugal;Spain;United Kingdom |
| 4 | NCT05414175 (ClinicalTrials.gov) | August 19, 2022 | 7/6/2022 | A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy | A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safety and Tolerability of Mavacamten in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy | Cardiomyopathy, Hypertrophic Obstructive | Drug: Mavacamten | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | Japan |
| 5 | JPRN-jRCT2031220178 | 21/06/2022 | 02/07/2022 | A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy( HORIZON-HCM ) | A Phase 3, Open-label, Single Arm, Clinical Study to Evaluate Efficacy, Safetyand Tolerability of Mavacamten in Adults With Symptomatic ObstructiveHypertrophic Cardiomyopathy | Obstructive Hypertrophic Cardiomyopathy | Single Group Assignment: Mavacamten Participants will receive treatment with 1, 2.5, 5, 10, 1mg dose once daily. | Florea Victoria | NULL | Pending | >= 18age old | Not applicable | Both | 30 | Phase 3 | Japan |
| 6 | NCT05174416 (ClinicalTrials.gov) | January 4, 2022 | 13/12/2021 | A Study to Evaluate the Efficacy and Safety of Mavacamten in Chinese Adults With Symptomatic Obstructive HCM | A 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 Cardiomyopathy | Obstructive Hypertrophic Cardiomyopathy | Drug: Mavacamten;Drug: Placebo | LianBio LLC | NULL | Active, not recruiting | 18 Years | 99 Years | All | 81 | Phase 3 | China |
| 7 | 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 | ||
| 8 | 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 | United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany | ||
| 9 | 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] | Product Name: Mavacamten Product Code: MYK-461 INN 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 | ||
| 10 | EUCTR2018-004039-64-PL (EUCTR) | 26/08/2019 | 10/06/2019 | 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;Poland;Belgium;Denmark;Germany;Netherlands | ||
| 11 | 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 | 250 | Phase 3 | United States;Czechia;United Kingdom;Portugal;Spain;Netherlands;Belgium;Poland;Denmark;Italy;Israel;France;Germany | ||
| 12 | 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] | Product Name: Mavacamten Product Code: MYK-461 INN 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Portugal;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Denmark;Germany;Netherlands | ||
| 13 | 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 | United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Netherlands;Germany | ||
| 14 | 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 | 250 | Phase 3 | Portugal;United States;Czechia;Spain;Israel;Italy;United Kingdom;France;Belgium;Poland;Denmark;Germany;Netherlands | ||
| 15 | 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 | ||
| 16 | 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 | United States;Portugal;Czechia;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Belgium;Poland;Denmark;Netherlands;Germany | ||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | ||
| 21 | 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 | ||
| 22 | 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 | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | N/A | All | 282 | Phase 2/Phase 3 | United States;Belgium;Czechia;Denmark;France;Germany;Israel;Italy;Netherlands;Poland;Portugal;Spain;United Kingdom |
| 23 | 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 | ||
| 24 | 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 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | Bristol-Myers Squibb | NULL | Active, not recruiting | 18 Years | N/A | All | 13 | Phase 2 | United States |
| 30 | 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 |