Sacubitril ( DrugBank: Sacubitril )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
58肥大型心筋症7

58. 肥大型心筋症


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
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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size
PhaseCountries
1EUCTR2019-003098-24-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
2EUCTR2019-003098-24-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
3EUCTR2019-003098-24-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
4EUCTR2019-003098-24-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
5NCT04164732
(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
6EUCTR2019-003098-24-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
7NCT03832660
(ClinicalTrials.gov)
May 3, 20191/2/2019Sacubitril/Valsartan vs Lifestyle in Hypertrophic CardiomyopathyClinical and Genetic Determinants of Disease Progression and Response to Sacubitril/Valsartan vs Lifestyle (Physical Activity and Dietary Nitrate) in Patients With Hypertrophic CardiomyopathyHypertrophic CardiomyopathyBehavioral: Lifestyle;Drug: Sacubitril/ValsartanNewcastle UniversityAzienda Ospedaliero-Universitaria Careggi;University Hospital Regensburg;Institute for Cardiovascular Diseases of Vojvodina;University of BelgradeRecruiting18 Years70 YearsAll240Phase 2Germany;Italy;Serbia;United Kingdom