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 | NCT05025644 (ClinicalTrials.gov) | March 2023 | 11/8/2021 | Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test | Quantitative Assessment of Hypertrophic Obstructive Cardiomyopathy With Intraoperative Three-dimensional Transesophageal Echocardiography Under Provocative Dobutamine Stress Test | Hypertrophic Obstructive Cardiomyopathy | Drug: Pre and post-CPB Drug: Dobutamine Hydrochloride;Drug: Post-CPB Drug: Dobutamine Hydrochloride | University Health Network, Toronto | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 4 | NULL |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 |
| 5 | NCT05569382 (ClinicalTrials.gov) | August 10, 2022 | 4/10/2022 | Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy | Treatment Effects of Bisoprolol and Verapamil in Symptomatic Patients With Non-obstructive Hypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Drug: Verapamil;Drug: Bisoprolol;Drug: Placebo | Morten Steen Kvistholm Jensen | Bispebjerg Hospital;Rigshospitalet, Denmark;Viborg Regional Hospital;Zealand University Hospital;Odense University Hospital;Gentofte University Hospital | Recruiting | 18 Years | N/A | All | 140 | Phase 4 | Denmark |
| 6 | 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 |
| 7 | NCT05182658 (ClinicalTrials.gov) | June 1, 2022 | 21/12/2021 | Empagliflozin in Hypertrophic Cardiomyopathy | The Use of Empagliflozin in Patients With Hypertrophic Cardiomyopathy | Hypertrophic Cardiomyopathy;Heart Failure | Drug: Empagliflozin 10 MG;Drug: Placebo | Institute of Cardiology, Warsaw, Poland | Medical University of Bialystok;University of Eastern Finland;Amsterdam UMC, location VUmc | Not yet recruiting | 18 Years | 70 Years | All | 250 | Phase 3 | Poland |
| 8 | EUCTR2021-006953-77-DK (EUCTR) | 11/04/2022 | 31/01/2022 | The effect of Bisoprolol and Verapamil in non-obstructive hypertrophic cardiomyopathy | Treatment effects of Bisoprolol and Verapamil in symptomatic patients with non-obstructive hypertrophic cardiomyopathy - TEMPO II | Non-obstructive Hypertrophic cardiomyopathy MedDRA version: 20.0;Level: PT;Classification code 10007636;Term: Cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0;Classification code 10049813;Term: Non-obstructive cardiomyopathy;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10061029;Term: Cardiomyopathy primary;System Organ Class: 10007541 - Cardiac disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Bisoprolol INN or Proposed INN: BISOPROLOL Trade Name: Isoptin INN or Proposed INN: VERAPAMIL HYDROCHLORIDE | Aarhus University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 2 | Denmark | ||
| 9 | 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 |
| 10 | NCT04905173 (ClinicalTrials.gov) | November 2021 | 23/5/2021 | Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy | Comparison of Squat-to-Stand Maneuver With Amyl Nitrite, Valsalva, and Exercise Stress Echocardiography in Inducing Latent Left Ventricular Outflow Obstruction in Hypertrophic Cardiomyopathy | Hypertrophic Cardiomyopathy;Hypertrophic Obstructive Cardiomyopathy;Cardiomyopathy, Hypertrophic | Other: Squat-to-stand maneuver;Drug: Amyl nitrite inhalation;Other: Valsalva | Mayo Clinic | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | N/A | United States |
| 11 | ChiCTR2100048388 | 2021-07-01 | 2021-07-06 | The prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathy | The prognostic value of myocardial fibrosis in patients with hypertrophic cardiomyopathy: a prospective study based on 18FAl-NOTA-FAPI-04 imaging | hypertrophic cardiomyopathy | Gold Standard:Clinical outcome;Index test:18FAl-NOTA-FAPI imaging quantitatively detect myocardial fibrosis; | Beijing Chaoyang Hospital, Capital Medical University | NULL | Pending | 14 | Both | Target condition:100;Difficult condition:0 | China | ||
| 12 | NCT04826185 (ClinicalTrials.gov) | June 14, 2021 | 18/3/2021 | A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy Trial | A Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Non-obstructive Hypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Drug: IMB-1018972;Drug: Placebo | Imbria Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 80 Years | All | 60 | Phase 2 | United States;United Kingdom |
| 13 | ChiCTR2000033626 | 2020-06-01 | 2020-06-07 | Endocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy | Endocardial Radiofrequency Septal Ablation Versus Alcohol Septal Ablation for Hypertrophic Obstructive Cardiomyopathy: a Randomized, Controlled, Open-Label Non-Inferiority Study | Hypertrophic Obstructive Cardiomyopathy | diofrequency ablation:radiofrequency ablation;Alcohol Ablation:Alcohol Septal Ablation; | Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | NULL | Recruiting | 18 | 75 | Both | diofrequency ablation:40;Alcohol Ablation:40; | China | |
| 14 | EUCTR2019-003098-24-GB (EUCTR) | 30/04/2020 | 21/02/2020 | Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of | ||
| 15 | EUCTR2019-003098-24-GR (EUCTR) | 16/04/2020 | 13/04/2020 | Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of | ||
| 16 | EUCTR2019-003098-24-FI (EUCTR) | 15/04/2020 | 02/03/2020 | Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 2 | United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of | ||
| 17 | EUCTR2019-003098-24-ES (EUCTR) | 19/02/2020 | 02/12/2019 | Study of efficacy of oral sacubitril/valsartan adult patients with non-obstructive hypertrophic cardiomyopathy | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | Greece;United States;Finland;Korea, Republic of;United Kingdom;Germany;Spain | ||
| 18 | NCT04219826 (ClinicalTrials.gov) | January 10, 2020 | 3/1/2020 | REDWOOD-HCM: Randomized Evaluation of Dosing With CK-3773274 in HCM | A Multi-Center, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy | Hypertrophic Cardiomyopathy (HCM) | Drug: CK-3773274 (5 - 15 mg);Drug: CK-3773274 (10 - 30 mg);Drug: Placebo for CK-3773274 | Cytokinetics | NULL | Active, not recruiting | 18 Years | 85 Years | All | 95 | Phase 2 | United States;Italy;Netherlands;Spain |
| 19 | NCT04164732 (ClinicalTrials.gov) | January 8, 2020 | 13/11/2019 | Study of Efficacy of Oral Sacubitril/Valsartan in Adult Patients With Non-obstructive Hypertrophic Cardiomyopathy | A 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, Hypertrophic | Drug: LCZ696;Drug: Placebo | Novartis Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 45 | Phase 2 | United States;Germany;Greece;Korea, Republic of;Spain;United Kingdom;Finland |
| 20 | EUCTR2019-003098-24-DE (EUCTR) | 18/12/2019 | 05/11/2019 | Study of efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 2 | United States;Greece;Finland;Spain;Germany;United Kingdom;Korea, Republic of | ||
| 21 | 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 | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 |
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | ||
| 33 | 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 | ||
| 34 | 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 |
| 35 | 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 |
| 36 | EUCTR2017-004478-32-DK (EUCTR) | 10/01/2018 | 14/12/2017 | The effect of metoprolol in hypertrophic obstructive cardiomyopathy | The 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 Hospital | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Denmark | ||
| 37 | NCT03251287 (ClinicalTrials.gov) | November 2017 | 11/8/2017 | Nitrite in Hypertrophic Cardiomyopathy (HCM) Study | Mechanistic Study of the Effect of Inorganic Sodium Nitrate on Cardiac and Skeletal Muscle Metabolic Efficiency in Patients With Hypertrophic Cardiomyopathy | Cardiomyopathy, Hypertrophic | Drug: Sodium Nitrate;Drug: Placebo;Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy;Diagnostic Test: Exercise Stress Transthoracic Echocardiogram | University of East Anglia | Norfolk and Norwich University Hospitals NHS Foundation Trust;British Medical Research Council | Recruiting | 18 Years | 80 Years | All | 18 | Phase 1 | United Kingdom |
| 38 | NCT03249272 (ClinicalTrials.gov) | September 5, 2017 | 8/8/2017 | Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve | Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve | Hypertrophic Cardiomyopathy;Non-ischemic Dilated Cardiomyopathy;Microvascular Ischaemia of Myocardium | Drug: Regadenoson;Drug: Adenosine | Duke University | NULL | Terminated | 18 Years | N/A | All | 31 | Phase 4 | United States |
| 39 | NCT03953989 (ClinicalTrials.gov) | October 2016 | 13/5/2019 | Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy | A Pilot Study Assessing the Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic Cardiomyopathy | HCM - Hypertrophic Non-Obstructive Cardiomyopathy | Drug: Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die | IRCCS San Raffaele | Menarini International Operations Luxembourg SA | Completed | 18 Years | 80 Years | All | 26 | Phase 2 | Italy |
| 40 | EUCTR2015-002283-16-DK (EUCTR) | 08/03/2016 | 16/12/2015 | An 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 Health | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | Denmark | ||
| 41 | EUCTR2015-002432-40-IT (EUCTR) | 03/03/2016 | 27/05/2021 | Safety and Efficacy of yIFN treatment in Friedreich ataxia | Safety 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.MEDEA | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Italy | ||
| 42 | NCT02560467 (ClinicalTrials.gov) | December 1, 2015 | 22/9/2015 | Perfusion Imaging With Myocardial Contrast Echocardiography in HCM | Hypertrophic Cardiomyopathy | Drug: Echo and myocardial contrast echocardiography perfusion imaging | Oregon Health and Science University | NULL | Active, not recruiting | 19 Years | 80 Years | All | 10 | N/A | United States | |
| 43 | EUCTR2013-004429-97-IT (EUCTR) | 15/05/2015 | 12/05/2015 | A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic Cardiomyopathy | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 44 | EUCTR2013-004429-97-NL (EUCTR) | 13/04/2015 | 17/12/2014 | A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic Cardiomyopathy | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Israel;Germany;Netherlands;Italy;United Kingdom | ||
| 45 | EUCTR2013-004429-97-GB (EUCTR) | 24/03/2015 | 05/11/2014 | A clinical trial with GS-6615 for treatment of Symptomatic Hypertrophic Cardiomyopathy | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of GS-6615 on Exercise Capacity in Subjects with Symptomatic Hypertrophic 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. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;United States;Australia;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 46 | EUCTR2014-001577-13-GB (EUCTR) | 15/07/2014 | 04/06/2014 | Trientine in Hypertrophic Cardiomyopathy | Copper 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 Trust | NULL | Not 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): yes | United Kingdom | ||
| 47 | NCT01904396 (ClinicalTrials.gov) | August 2013 | 15/7/2013 | Identification of Carnitine-Responsive Cardiomyopathy | Identification of Carnitine-responsive Cardiomyopathy and Myopathy in Adult Patients With Dilated and/or Hypertrophic Cardiomyopathy and Limb Girdle Weakness. | Carnitine Deficiency | Drug: Carnitine | University Health Network, Toronto | The Physicians' Services Incorporated Foundation | Not yet recruiting | 18 Years | N/A | Both | 30 | Phase 4 | Canada |
| 48 | NCT01721967 (ClinicalTrials.gov) | November 2012 | 2/11/2012 | Ranolazine for the Treatment of Chest Pain in HCM Patients | Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation | Hypertrophic Cardiomyopathy | Drug: Ranolazine | Duke University | Gilead Sciences | Completed | 18 Years | N/A | All | 14 | Phase 4 | United States |
| 49 | EUCTR2011-004507-20-DE (EUCTR) | 02/07/2012 | 17/10/2011 | SHCM | RANOLAZINE 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. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Spain;Germany;Italy | |||
| 50 | NCT01696370 (ClinicalTrials.gov) | April 2012 | 27/9/2012 | Trimetazidine Therapy in Hypertrophic Cardiomyopathy | A Phase 2b Randomised, Double Blind, Placebo-controlled Trial of Trimetazidine Therapy in Patients With Non-obstructive Hypertrophic Cardiomyopathy | Hypertrophic Cardiomyopathy | Drug: Trimetazidine;Other: Placebo capsule | University College, London | British Heart Foundation | Recruiting | 18 Years | N/A | Both | 90 | Phase 2 | United Kingdom |
| 51 | EUCTR2011-004507-20-IT (EUCTR) | 22/02/2012 | 08/03/2012 | SHMC | RANOLAZINE 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. | NULL | Not 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): no | Spain;Germany;Italy | ||
| 52 | NCT01556568 (ClinicalTrials.gov) | February 2012 | 15/3/2012 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy | An Open Label Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEK162 in Noonan Syndrome Hypertrophic Cardiomyopathy | Cardiomegaly | Drug: MEK162 | Array Biopharma, now a wholly owned subsidiary of Pfizer | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2 | United States;United Kingdom |
| 53 | EUCTR2011-003392-10-GB (EUCTR) | 23/01/2012 | 24/08/2011 | A 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: MEK162 | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 22 | United Kingdom;United States | |||
| 54 | EUCTR2011-004507-20-ES (EUCTR) | 19/01/2012 | 13/10/2011 | SHMC | RANOLAZINE 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. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Spain;Germany;Italy | |||
| 55 | NCT01447654 (ClinicalTrials.gov) | November 2011 | 4/10/2011 | Inhibition of the Renin Angiotensin System With Losartan in Patients With Hypertrophic Cardiomyopathy | INHibition of the Renin Angiotensin System in Hypertrophic Cardiomyopathy and the Effect on Ventricular Hypertrophy - a Randomized Intervention Trial With Losartan. | Hypertrophic Cardiomyopathy | Drug: Losartan;Drug: Placebo | Henning Bundgaard | NULL | Completed | 18 Years | N/A | Both | 130 | Phase 2 | Denmark |
| 56 | EUCTR2011-001191-19-DK (EUCTR) | 26/10/2011 | 12/09/2011 | Effects 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, Rigshospitalet | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 57 | EUCTR2011-000038-12-GB (EUCTR) | 13/09/2011 | 17/08/2011 | Trimetazidine therapy in Hypertrophic Cardiomyopathy | A 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) | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 58 | NCT00879060 (ClinicalTrials.gov) | November 2007 | 8/4/2009 | Clinical and Therapeutic Implications of Fibrosis in Hypertrophic Cardiomyopathy | Clinical and Therapeutic Implications of Fibrosis in Hypertrophic | Myocardial Fibrosis;Hypertrophic Cardiomyopathy | Drug: spironolactone | Tufts Medical Center | NULL | Recruiting | 18 Years | 70 Years | Both | 95 | Phase 4 | United States |
| 59 | NCT00430833 (ClinicalTrials.gov) | March 2007 | 31/1/2007 | CHANCE - Candesartan in Hypertrophic Cardiomyopathy | Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter Study | Hypertrophic Cardiomyopathy | Drug: candesartan | Charles University, Czech Republic | AstraZeneca | Active, not recruiting | 18 Years | N/A | Both | Phase 2 | Czech Republic | |
| 60 | NCT01150461 (ClinicalTrials.gov) | February 2007 | 22/6/2010 | Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy | Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy | Hypertrophic Cardiomyopathy | Drug: losartan;Drug: placebo | Massachusetts General Hospital | NULL | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 61 | NCT00011076 (ClinicalTrials.gov) | February 2001 | 9/2/2001 | Pirfenidone to Treat Hypertrophic Cardiomyopathy | Double-Blind Placebo-Controlled Study of Pirfenidone, A Novel Anti-Fibrotic Drug in Symptomatic Patients With Hypertrophic Cardiomyopathy (HCM) Associated With Left Ventricular Diastolic Function | Hypertrophic Cardiomyopathy | Drug: Pirfenidone | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | N/A | N/A | Both | 50 | Phase 2 | United States |
| 62 | NCT00001534 (ClinicalTrials.gov) | September 1996 | 3/11/1999 | Long Term Effects of Enalapril and Losartan on Genetic Heart Disease | Double-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 HCM | Hypertrophic Cardiomyopathy;Left Ventricular Hypertrophy;Myocardial Ischemia | Drug: Losartan | National Heart, Lung, and Blood Institute (NHLBI) | NULL | Completed | N/A | N/A | Both | 112 | N/A | United States |