RANOLAZINE ( DrugBank: Ranolazine )


6 diseases
告示番号疾患名(ページ内リンク)臨床試験数
2筋萎縮性側索硬化症1
58肥大型心筋症6
86肺動脈性肺高血圧症2
96クローン病1
113筋ジストロフィー1
114非ジストロフィー性ミオトニー症候群1

2. 筋萎縮性側索硬化症


臨床試験数 : 645 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03472950
(ClinicalTrials.gov)
June 11, 20181/3/2018Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral SclerosisSafety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral SclerosisALSDrug: Ranolazine 500 MG;Drug: Ranolazine 1000 MGUniversity of Kansas Medical CenterGilead SciencesRecruiting18 YearsN/AAll20Phase 2United States

58. 肥大型心筋症


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004402-42-IT
(EUCTR)
06/10/201609/09/2021A pilot study assessing the effects of Ranolazine on small heart vessels dysfunction in patients with hypertrophic cardiomyopathyA pilot study assessing the effects of Ranolazine on coronary microvascular dysfunction in patients with hypertrophic cardiomyopathy - Ranolazine microvascular dysfunction HCM Hypertrophic cardiomyopathy
MedDRA version: 20.0;Level: PT;Classification code 10020871;Term: Hypertrophic cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.1;Level: LLT;Classification code 10020204;Term: HOCM Hypertrophic obstructive cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10020203;Term: HOCM;Classification code 10020876;Term: Hypertrophic obstructive cardiomyopathy;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Trade Name: RANEXA - 750 MG - COMPRESSA A RILASCIO PROLUNGATO- USO ORALE - BLISTER (PVC/PVDC/ALLUMINIO) 60 COMPRESSE
Product Name: Ranolazina Ranexa
Product Code: [C01EB18]
OSPEDALE SAN RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Italy
2NCT03953989
(ClinicalTrials.gov)
October 201613/5/2019Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic CardiomyopathyA Pilot Study Assessing the Effects of Ranolazine on Coronary Microvascular Dysfunction in Patients With Hypertrophic CardiomyopathyHCM - Hypertrophic Non-Obstructive CardiomyopathyDrug: Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in dieIRCCS San RaffaeleMenarini International Operations Luxembourg SACompleted18 Years80 YearsAll26Phase 2Italy
3NCT01721967
(ClinicalTrials.gov)
November 20122/11/2012Ranolazine for the Treatment of Chest Pain in HCM PatientsRanolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy InvestigationHypertrophic CardiomyopathyDrug: RanolazineDuke UniversityGilead SciencesCompleted18 YearsN/AAll14Phase 4United States
4EUCTR2011-004507-20-DE
(EUCTR)
02/07/201217/10/2011SHCMRANOLAZINE 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.NULLNot RecruitingFemale: yes
Male: yes
100Spain;Germany;Italy
5EUCTR2011-004507-20-IT
(EUCTR)
22/02/201208/03/2012SHMCRANOLAZINE 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.NULLNot 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): noSpain;Germany;Italy
6EUCTR2011-004507-20-ES
(EUCTR)
19/01/201213/10/2011SHMCRANOLAZINE 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.NULLNot RecruitingFemale: yes
Male: yes
100Spain;Germany;Italy

86. 肺動脈性肺高血圧症


臨床試験数 : 1,205 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01757808
(ClinicalTrials.gov)
August 201126/4/2012A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionA Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial HypertensionPulmonary Arterial HypertensionDrug: Ranolazine;Drug: PlaceboUniversity of ChicagoNULLCompleted18 Years72 YearsAll12Phase 1United States
2NCT01174173
(ClinicalTrials.gov)
June 201023/7/2010Ranolazine and Pulmonary HypertensionEffects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial HypertensionAngina;Pulmonary Arterial HypertensionDrug: RanolazineNorthwestern UniversityGilead SciencesCompleted18 Years80 YearsAll11Phase 3United States

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04456517
(ClinicalTrials.gov)
October 18, 202229/6/2020Reduce Crohn's-Associated Diarrhea With Sodium Channel TherapyREACT Trial: A Randomized, Double Blind, Placebo-controlled, Crossover Study of Ranolazine for the Treatment of Crohn's Disease-associated DiarrheaCrohn's Disease;Inflammatory Bowel DiseaseDrug: Ranolazine;Drug: PlaceboVanderbilt University Medical CenterNULLEnrolling by invitation18 YearsN/AAll16Phase 2United States

113. 筋ジストロフィー


臨床試験数 : 646 薬物数 : 471 - (DrugBank : 105) / 標的遺伝子数 : 59 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02251457
(ClinicalTrials.gov)
August 201425/9/2014Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1Open Label Trial of Ranolazine in Myotonia Congenita, Paramyotonia Congenita, & Myotonic Dystrophy Type 1Myotonia Congenita;Paramyotonia Congenita;Myotonic Dystrophy 1Drug: RanolazineOhio State UniversityGilead SciencesCompleted18 Years100 YearsAll35Phase 1United States

114. 非ジストロフィー性ミオトニー症候群


臨床試験数 : 13 薬物数 : 19 - (DrugBank : 5) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 10
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02251457
(ClinicalTrials.gov)
August 201425/9/2014Study of Ranolazine in Myotonia Congenita, Paramyotonia Congenita and Myotonic Dystrophy Type 1Open Label Trial of Ranolazine in Myotonia Congenita, Paramyotonia Congenita, & Myotonic Dystrophy Type 1Myotonia Congenita;Paramyotonia Congenita;Myotonic Dystrophy 1Drug: RanolazineOhio State UniversityGilead SciencesCompleted18 Years100 YearsAll35Phase 1United States