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

  
54 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04905173
(ClinicalTrials.gov)
November 202123/5/2021Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic CardiomyopathyComparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic CardiomyopathyHypertrophic Cardiomyopathy;Hypertrophic Obstructive Cardiomyopathy;Cardiomyopathy, HypertrophicOther: Squat-to-stand maneuver;Drug: Amyl nitrite inhalation;Other: ValsalvaMayo ClinicNULLNot yet recruiting18 YearsN/AAll200N/AUnited States
2NCT05025644
(ClinicalTrials.gov)
August 202111/8/2021Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress TestQuantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress TestHypertrophic Obstructive CardiomyopathyDrug: Pre and post-CPB Drug: Dobutamine Hydrochloride;Drug: Post-CPB Drug: Dobutamine HydrochlorideUniversity Health Network, TorontoNULLNot yet recruiting18 YearsN/AAll60Phase 4NULL
3ChiCTR2100048388
2021-07-012021-07-06The prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathyThe prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathy: a prospective study based on 18FAl-NOTA-FAPI-04 imaging hypertrophic cardiomyopathyGold Standard:Clinical outcome;Index test:18FAl-NOTA-FAPI imaging quantitatively detect myocardial fibrosis;Beijing Chaoyang Hospital, Capital Medical UniversityNULLPending14BothTarget condition:100;Difficult condition:0China
4NCT04826185
(ClinicalTrials.gov)
June 14, 202118/3/2021A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy TrialA Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic CardiomyopathyNon-obstructive Hypertrophic CardiomyopathyDrug: IMB-1018972;Drug: PlaceboImbria Pharmaceuticals, Inc.NULLRecruiting18 Years75 YearsAll60Phase 2United States;United Kingdom
5NCT04349072
(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
6ChiCTR2000033626
2020-06-012020-06-07Endocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive CardiomyopathyEndocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: a Randomized, Controlled, Open-Label Non-Inferiority Study Hypertrophic Obstructive Cardiomyopathydiofrequency ablation:radiofrequency ablation;Alcohol Ablation:Alcohol Septal Ablation;Sir Run Run Shaw Hospital, Zhejiang University School of MedicineNULLRecruiting1875Bothdiofrequency ablation:40;Alcohol Ablation:40;China
7EUCTR2019-003098-24-GB
(EUCTR)
30/04/202021/02/2020Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
8EUCTR2019-003098-24-GR
(EUCTR)
16/04/202013/04/2020Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
9EUCTR2019-003098-24-FI
(EUCTR)
15/04/202002/03/2020Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
10EUCTR2019-003098-24-ES
(EUCTR)
19/02/202002/12/2019Study of efficacy of oral sacubitril/valsartan adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
11NCT04164732
(ClinicalTrials.gov)
January 8, 202013/11/2019Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic CardiomyopathyA Multi-center, Randomized, Placebo-controlled Patient and Investigator-blinded Study to Explore the Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy (nHCM)Cardiomyopathy, HypertrophicDrug: LCZ696;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll44Phase 2United States;Finland;Germany;Greece;Korea, Republic of;Spain;United Kingdom
12EUCTR2019-003098-24-DE
(EUCTR)
18/12/201905/11/2019Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathyA multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM) non-obstructive hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
44Phase 2United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of
13EUCTR2018-004039-64-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
14EUCTR2017-002530-23-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
15EUCTR2017-002530-23-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
16EUCTR2017-002530-23-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
17EUCTR2017-002530-23-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
18EUCTR2017-002530-23-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
19EUCTR2017-002530-23-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
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
25NCT03496168
(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
26NCT03442764
(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
27EUCTR2017-004478-32-DK
(EUCTR)
10/01/201814/12/2017The effect of metoprolol in hypertrophic obstructive cardiomyopathyThe effect of metoprolol on myocardial function, hemodynamics and heart failure symptoms in patients with hypertrophic obstructive cardiomyopathy - TEMPO Hypertrophic obstructive cardiomyopathy
MedDRA version: 20.0;Level: LLT;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Metoprololsuccinat
INN or Proposed INN: metoprololsuccinat
Other descriptive name: METOPROLOL SUCCINATE
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Denmark
28NCT03251287
(ClinicalTrials.gov)
November 201711/8/2017Nitrite in Hypertrophic Cardiomyopathy (HCM) StudyMechanistic Study of the Effect of Inorganic Sodium Nitrate on Cardiac and Skeletal Muscle Metabolic Efficiency in Patients With Hypertrophic CardiomyopathyCardiomyopathy, HypertrophicDrug: Sodium Nitrate;Drug: Placebo;Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy;Diagnostic Test: Exercise Stress Transthoracic EchocardiogramUniversity of East AngliaNorfolk and Norwich University Hospitals NHS Foundation Trust;British Medical Research CouncilRecruiting18 Years80 YearsAll18Phase 1United Kingdom
29NCT03249272
(ClinicalTrials.gov)
September 5, 20178/8/2017Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow ReserveMicrovascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow ReserveHypertrophic Cardiomyopathy;Non-ischemic Dilated Cardiomyopathy;Microvascular Ischaemia of MyocardiumDrug: Regadenoson;Drug: AdenosineDuke UniversityNULLTerminated18 YearsN/AAll31Phase 4United States
30NCT03049995
(ClinicalTrials.gov)
November 20162/2/2017Stress Echo 2020 - The International Stress Echo StudyThe International Stress Echo Study in Ischemic and Non-ischemic Heart DiseaseCoronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial HypertensionProcedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SEFatebenefratelli HospitalInstitute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre;University of Parma;Hospital Clinics, Trieste, Italy;Federal University of Rio Grande do Sul;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic Tokuda Hospital;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian Federation;Instituto Nacional de Cardiología Mexico City, Mexico;Hamad Medical Corporation, Heart Hospital -Doha-QatarRecruiting18 Years85 YearsAll300Italy
31NCT03953989
(ClinicalTrials.gov)
October 201613/5/2019Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic CardiomyopathyA Pilot Study Assessing the Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic CardiomyopathyHCM - Hypertrophic Non-Obstructive CardiomyopathyDrug: Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in dieIRCCS San RaffaeleMenarini International Operations Luxembourg SACompleted18 Years80 YearsAll26Phase 2Italy
32EUCTR2015-002283-16-DK
(EUCTR)
08/03/201616/12/2015An international study of the effect of Valsartan in hypertrophic cardiomyopathy.Phase II randomized, placebo-controlled, double blind clinical trial of valsartan for attenuating disease evolution in early sarcomeric HCM - VANISH Hypertrophic cardiomyopathy
MedDRA version: 19.0;Level: LLT;Classification code 10020204;Term: HOCM Hypertrophic obstructive cardiomyopathy;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Diovan 40 mg
INN or Proposed INN: VALSARTAN
Other descriptive name: Diovan
Trade Name: Diovan 80 mg
INN or Proposed INN: VALSARTAN
Other descriptive name: Diovan
Trade Name: Diovan 160 mg
INN or Proposed INN: VALSARTAN
National Heart, Lung, and Blood Institute / National Institutes of HealthNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Denmark
33EUCTR2015-002432-40-IT
(EUCTR)
03/03/201627/05/2021Safety and Efficacy of yIFN treatment in Friedreich ataxiaSafety and Efficacy of yIFN treatment in Friedreich ataxia - ¿IFN in Friedreich Ataxia FRDA is a progressive neurodegenerative disease inherited as recessive trait. It manifests itself usually in adolescence and affects various systems including the central and peripheral nervous system (balance, coordination, speech and sensitivity), the heart with hypertrophic cardiomyopathy, the bones with skeletal deformities (scoliosis, claw foot) and in some cases diabetes mellitus. The disease causes severe and progressive disability, significantly reducing the life expectancy of patients.
MedDRA version: 20.0;Level: PT;Classification code 10017374;Term: Friedreich's ataxia;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: IMUKIN - 6 FLACONI 0.5 ML 100 MCG
Product Name: Imukin
ASSOCIAZIONE LA NOSTRA FAMIGLIA - SEZIONE SCIENTIFICA I.R.C.C.S. E.MEDEANULLNot RecruitingFemale: yes
Male: yes
12Phase 2Italy
34NCT02560467
(ClinicalTrials.gov)
December 1, 201522/9/2015Perfusion Imaging With Myocardial Contrast Echocardiography in HCMHypertrophic CardiomyopathyDrug: Echo and myocardial contrast echocardiography perfusion imagingOregon Health and Science UniversityNULLActive, not recruiting19 Years80 YearsAll10N/AUnited States
35EUCTR2013-004429-97-IT
(EUCTR)
15/05/201512/05/2015A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic CardiomyopathyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy - NA Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed)
MedDRA version: 18.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: GS-6615 3 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Code: GS-6615 6 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Israel;Netherlands;Germany;United Kingdom;Italy
36EUCTR2013-004429-97-NL
(EUCTR)
13/04/201517/12/2014A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic CardiomyopathyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed)
MedDRA version: 18.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: GS-6615 3 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Code: GS-6615 6 mg
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Israel;Germany;Netherlands;Italy;United Kingdom
37EUCTR2013-004429-97-GB
(EUCTR)
24/03/201505/11/2014A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic CardiomyopathyA Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic Cardiomyopathy Subjects with symptoms (NYHA Class = II dyspnea or CCS Class = II angina) due to hypertrophic cardiomyopathy (defined by standard criteria as a maximal LV wall thickness of = 15 mm in the absence of other causative loading abnormalities capable of producing the magnitude of hypertrophy observed)
MedDRA version: 19.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Name: GS-6615 3 mg White
Product Code: GS-6615 3 mg White
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Name: GS-6615 6 mg White
Product Code: GS-6615 6 mg White
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4-(trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4-(trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Product Name: GS-6615 3 mg Pink
Product Code: GS-6615 3 mg Pink
INN or Proposed INN: No INN or proposed INN available
Other descriptive name: CAS Name: 1,4-Benzoxazepin-5(2H)-one, 3,4-dihydro-4-(2-pyrimidinylmethyl)-7-[4- (trifluoromethoxy)phenyl] IUPAC Name: 4-(Pyrimidin-2-ylmethyl)-7-[4- (trifluoromethoxy)phenyl]-3,4-dihydro-1,4-benzoxazepin-5(2H)-one
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;United States;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
38EUCTR2014-001577-13-GB
(EUCTR)
15/07/201404/06/2014Trientine in Hypertrophic CardiomyopathyCopper Chelation in Hypertrophic Cardiomyopathy: Open-label pilot study of Trientine in patients with hypertrophic cardiomyopathy - Copper (II) Chelation therapy in the treatment of HCM Hypertrophic Cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Trientine dihydrochloride
Product Name: Trientine dihydrochloride
INN or Proposed INN: Trientine Dihydrochloride
Manchester University NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
39NCT01904396
(ClinicalTrials.gov)
August 201315/7/2013Identification of Carnitine-Responsive CardiomyopathyIdentification of Carnitine-responsive Cardiomyopathy and Myopathy in Adult Patients With Dilated and/or Hypertrophic Cardiomyopathy and Limb Girdle Weakness.Carnitine DeficiencyDrug: CarnitineUniversity Health Network, TorontoThe Physicians' Services Incorporated FoundationNot yet recruiting18 YearsN/ABoth30Phase 4Canada
40NCT01721967
(ClinicalTrials.gov)
November 20122/11/2012Ranolazine for the Treatment of Chest Pain in HCM PatientsRanolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy InvestigationHypertrophic CardiomyopathyDrug: RanolazineDuke UniversityGilead SciencesCompleted18 YearsN/AAll14Phase 4United States
41EUCTR2011-004507-20-DE
(EUCTR)
02/07/201217/10/2011SHCMRANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS (RESTYLE- HCM STUDY) - RESTYLE- HCM STUDY symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 17.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ranexa
Product Code: Ranolazine 500 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 750 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 1000 mg PR tablets
INN or Proposed INN: RANOLAZINE
Menarini International Operations Luxembourg S.A.NULLNot RecruitingFemale: yes
Male: yes
100Spain;Germany;Italy
42NCT01696370
(ClinicalTrials.gov)
April 201227/9/2012Trimetazidine Therapy in Hypertrophic CardiomyopathyA Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: Trimetazidine;Other: Placebo capsuleUniversity College, LondonBritish Heart FoundationRecruiting18 YearsN/ABoth90Phase 2United Kingdom
43EUCTR2011-004507-20-IT
(EUCTR)
22/02/201208/03/2012SHMCRANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 14.1;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: RANEXA*60CPR 500MG R.P.
INN or Proposed INN: RANOLAZINE
Other descriptive name: NA
Trade Name: RANEXA*60CPR 750MG R.P.
INN or Proposed INN: RANOLAZINE
Other descriptive name: NA
Trade Name: RANEXA
INN or Proposed INN: RANOLAZINE
Other descriptive name: NA
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.NULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Germany;Italy
44NCT01556568
(ClinicalTrials.gov)
February 201215/3/2012Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyAn Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic CardiomyopathyCardiomegalyDrug: MEK162Array Biopharma, now a wholly owned subsidiary of PfizerNULLWithdrawn18 Years65 YearsAll0Phase 2United States;United Kingdom
45EUCTR2011-003392-10-GB
(EUCTR)
23/01/201224/08/2011A study to look at the effect of the study drug on heart muscle thickness, the amount of drug that ends up in the blood, and the safety and tolerability of study drug in Noonan syndrome patients.An open label study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of MEK162 in Noonan syndrome hypertrophic cardiomyopathy. Noonan syndrome hypertrophic cardiomyopathy
MedDRA version: 14.1;Level: PT;Classification code 10029748;Term: Noonan syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Product Code: MEK162Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
22United Kingdom;United States
46EUCTR2011-004507-20-ES
(EUCTR)
19/01/201213/10/2011SHMCRANOLAZINE IN PATIENTS WITH SYMPTOMATICHYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDYASSESSING THE EFFECTS ON EXERCISE CAPACITY,DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS symptomatic hypertrophic cardiomyopathy (SHCM)
MedDRA version: 14.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Ranexa
Product Code: Ranolazine 500 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 750 mg PR tablets
INN or Proposed INN: RANOLAZINE
Trade Name: Ranexa
Product Name: Ranolazine 1000 mg PR tablets
INN or Proposed INN: RANOLAZINE
Menarini International Operations Luxembourg S.A.NULLNot RecruitingFemale: yes
Male: yes
100Spain;Germany;Italy
47NCT01447654
(ClinicalTrials.gov)
November 20114/10/2011Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic CardiomyopathyINHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan.Hypertrophic CardiomyopathyDrug: Losartan;Drug: PlaceboHenning BundgaardNULLCompleted18 YearsN/ABoth130Phase 2Denmark
48EUCTR2011-001191-19-DK
(EUCTR)
26/10/201112/09/2011Effects on the heart in patients with hypertophic cardiomyopathy when treated with losartan.Cardiac effects of inhibition of the renin angiotensin system with losartan in patients with hypertrophic cardiomyopathy. Hypertrophic cardiomyopathy
MedDRA version: 14.0;Level: LLT;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Losartan Bluefish 50 mg
Product Name: Losartan
Hjertemedicinsk klinik B, 2142, RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
Denmark
49EUCTR2011-000038-12-GB
(EUCTR)
13/09/201117/08/2011Trimetazidine therapy in Hypertrophic CardiomyopathyA Phase 2b randomised, double blind, placebo-controlled trial of trimetazidine therapy in patients with non-obstructive hypertrophic cardiomyopathy. - Trimetazidine therapy in hypertrophic cardiomyopathy Hypertrophic cardiomyopathy (non-obstructive)
MedDRA version: 16.1;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: Vastarel 20mg film coated tablets
Product Name: Trimetazidine Dihydrochloride 20mg
Product Code: not applicable
INN or Proposed INN: trimetazidine dihydrochloride
Other descriptive name: 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride
University College London (UCL)NULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
50NCT00879060
(ClinicalTrials.gov)
November 20078/4/2009Clinical and Therapeutic Implications of Fibrosis in Hypertrophic CardiomyopathyClinical and Therapeutic Implications of Fibrosis in HypertrophicMyocardial Fibrosis;Hypertrophic CardiomyopathyDrug: spironolactoneTufts Medical CenterNULLRecruiting18 Years70 YearsBoth95Phase 4United States
51NCT00430833
(ClinicalTrials.gov)
March 200731/1/2007CHANCE - Candesartan in Hypertrophic CardiomyopathyCandesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter StudyHypertrophic CardiomyopathyDrug: candesartanCharles University, Czech RepublicAstraZenecaActive, not recruiting18 YearsN/ABothPhase 2Czech Republic
52NCT01150461
(ClinicalTrials.gov)
February 200722/6/2010Effect of Losartan in Patients With Nonobstructive Hypertrophic CardiomyopathyEffect of Losartan in Patients With Nonobstructive Hypertrophic CardiomyopathyHypertrophic CardiomyopathyDrug: losartan;Drug: placeboMassachusetts General HospitalNULLCompleted18 YearsN/AAll20Phase 2United States
53NCT00011076
(ClinicalTrials.gov)
February 20019/2/2001Pirfenidone to Treat Hypertrophic CardiomyopathyDouble-Blind Placebo-Controlled Study of Pirfenidone, A Novel Anti-Fibrotic Drug in Symptomatic Patients With Hypertrophic Cardiomyopathy (HCM) Associated With Left Ventricular Diastolic FunctionHypertrophic CardiomyopathyDrug: PirfenidoneNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth50Phase 2United States
54NCT00001534
(ClinicalTrials.gov)
September 19963/11/1999Long Term Effects of Enalapril and Losartan on Genetic Heart DiseaseDouble-Blind, Placebo-Controlled Study of the Long Term Effects of Angiotensin Converting Enzyme Inhibition (Enalapril) and Angiotensin II Receptor Blockade (Losartan) on Genetically-Induced Left Ventricular Hypertrophy in Non-Obstructive HCMHypertrophic Cardiomyopathy;Left Ventricular Hypertrophy;Myocardial IschemiaDrug: LosartanNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth112N/AUnited States