DDrare: Database of Drug Development for Rare Diseases

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	1

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.

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

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