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	2

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	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
2	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

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

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

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]

Menarini International Operations Luxembourg S.A.

NULL

Not Recruiting

Female: yes
Male: yes

100

Spain;Germany;Italy