DDrare: Database of Drug Development for Rare Diseases

Searched query = "Hypertrophic cardiomyopathy"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = (R)-N-(5-(5-ETHYL-1,2,4-OXADIAZOL-3-YL)-2,3-DIHYDRO-1H-INDEN-1-YL)-1-METHYL-1H-PYRAZOLE-4-CARBOXAMIDE; 1-(2,3,4-Trimethoxybenzyl)piperazine dihydrochloride; Acetylcysteine; Adenosine; Air; Alcohol; Antiarrhythmic drugs; Atorvastatin; BNP; BNP blood sample test; Behavioral: Lifestyle; Bluefish; 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; 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; CK-3773274; CK-3773274 (10 - 30 mg); CK-3773274 (5 - 15 mg); CK-3773274 - Granules in Capsule; CK-3773274 - Tablets; CT-G20; Candesartan; Carnitine; Cufence; Cyclosporine; Cyclosporine A; Device: Insertable cardiac monitor; Device: Magnetic resonance imaging (MRI) with gadolinium enhancement; Device: Magnetic resonance imaging (MRI) without gadolinium enhancement; Device: Use of bioanalytical assay to monitor plasma levels of perhexiline; Diagnostic Test: Air venous plethysmography; Diagnostic Test: Echocardiography; Diagnostic Test: Electrocardiogram; Diagnostic Test: Exercise Stress Transthoracic Echocardiogram; Diagnostic Test: Holter ECG; Diagnostic Test: Phosphorous Magnetic Resonance Spectroscopy; Diagnostic Test: Upper member arterial Doppler echography with analysis of FMD; Diltiazem; Diovan; Diovan 160 mg; Diovan 40 mg; Diovan 80 mg; Dobutamine; Echo and myocardial contrast echocardiography perfusion imaging; Eleclazine; Endothelial function biomarkers; Entresto; GS-6615 3 mg; GS-6615 3 mg Pink; GS-6615 3 mg White; GS-6615 6 mg; GS-6615 6 mg White; Gadolinium; Gradient; Gutron 2,5mg; Gutron 5mg; Hyperpolarized 13C-Pyruvate; LCZ696; LCZ696 100 mg; LCZ696 200 mg; LCZ696 50 mg; Losartan; Losartan Bluefish 50 mg; MAVACAMTEN; MEK162; MIDODRINE HYDROCHLORIDE; MONITOR; MYK-461; Mangafodipir; Mavacamten; Metoprolol; Metoprolol Succinate; Midodrine; N-acetylcysteine; Nitrate; Other: Exercise echocardiography; Other: Mangafodipir trisodium; Other: Walk distance test; Perhexiline; Perxexiline; Pexsig; Phosphorous; Piperazine; Pirfenidone; Procedure: 3D electrocardiographic mapping (ECM); Procedure: B-lines SE; Procedure: Coronary flow reserve SE; Procedure: Diastolic function SE; Procedure: Echocardiography (TEE); Procedure: Left ventricular contractile reserve SE; Procedure: Left ventricular outflow tract gradient SE; Procedure: Mitral regurgitation SE; Procedure: Pulmonary hemodynamics SE; Procedure: RF catheter ablation; Procedure: trans-right ventricular alcohol septal ablation (TRVASA); Pyrazole; RANEXA; RANEXA*60CPR 500MG R.P.; RANEXA*60CPR 750MG R.P.; RANOLAZINE; Ranexa; Ranolazine; Ranolazine 1000 mg PR tablets; Ranolazine 500 mg PR tablets; Ranolazine 750 mg PR tablets; Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die; Regadenoson; SACUBITRIL VALSARTAN; Sacubitril; Sacubitril/Valsartan; Sacubitril/valsartan; Sodium Nitrate; Sodium nitrate; Spironolactone; Treatment BX1514M; Trientine; Trientine Dihydrochloride; Trientine dihydrochloride; Triethylinetetramine dihydrochloride; Trimetazidine; Trimetazidine Dihydrochloride 20mg; Trimetazidine dihydrochloride; VALSARTAN; Valsartan; Vastarel; Vastarel 20mg film coated tablets; [MYK-461]

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	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

No.

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registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

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sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
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Phase

Countries

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