EZETIMIBE ( DrugBank: Ezetimibe )


4 diseases
IDDisease name (Link within this page)Number of trials
49Systemic lupus erythematosus1
79Homozygous familial hypercholesterolemia6
93Primary biliary cholangitis1
260Sitosterolemia11

49. Systemic lupus erythematosus


Clinical trials : 993 Drugs : 702 - (DrugBank : 184) / Drug target genes : 116 - Drug target pathways : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02548936
(ClinicalTrials.gov)
April 201531/8/2015Efficacy and Safety of Simvastatin-ezetimibe Combination Therapy Among Patients With SLEEfficacy and Safety of Simvastatin-ezetimibe Combination Therapy in Reduction of Progression of Atherosclerosis Among Patients With Systemic Lupus Erythematosus: A Randomized Single-Blind TrialAtherosclerosisDrug: Ezetimibe+Simvastatin Drug CombinationPeking Union Medical College HospitalNULLEnrolling by invitation18 Years65 YearsBoth30Phase 0China

79. Homozygous familial hypercholesterolemia


Clinical trials : 145 Drugs : 114 - (DrugBank : 26) / Drug target genes : 8 - Drug target pathways : 17
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03933293
(ClinicalTrials.gov)
May 13, 201928/4/2019A Study to Evaluate the Safety and Efficacy of the PCSK9 Inhibitor AK102 in Patients With HoFHA Phase 2 Study to Evaluate the Safety and Efficacy of PCSK9 Inhibitor AK102 in Patients With Homozygous Familial Hypercholesterolemia (HoFH)Homozygous Familial HypercholesterolemiaDrug: AK102;Drug: Statins;Drug: EzetimibeAkesoAD Pharmaceuticals Co., Ltd.Completed18 YearsN/AAll10Phase 2China
2NCT03510715
(ClinicalTrials.gov)
August 31, 201818/4/2018An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial HypercholesterolemiaAn Open-Label Study to Evaluate the Efficacy and Safety of Alirocumab in Children and Adolescents With Homozygous Familial HypercholesterolemiaHypercholesterolemiaDrug: Alirocumab SAR236553 (REGN727);Drug: Rosuvastatin;Drug: Ezetimibe;Drug: Cholestyramine;Drug: Nicotinic acid;Drug: Fenofibrate;Drug: Omega-3 fatty acids;Drug: Atorvastatin;Drug: Simvastatin;Drug: Fluvastatin;Drug: Pravastatin;Drug: LovastatinSanofiRegeneron PharmaceuticalsCompleted8 Years17 YearsAll18Phase 3Brazil;Canada;Denmark;Mexico;Netherlands;Russian Federation;Slovenia;Spain;Taiwan;Turkey;Austria;France;Italy;Norway;United States
3NCT00704535
(ClinicalTrials.gov)
March 200623/6/2008Evaluation of the Safety, Tolerability and Efficacy of Ezetimibe on a Select Population of Filipinos With Hypercholesterolemia (Study P04748)(COMPLETED)Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Ezetimibe Among Filipino PatientsPrimary Hypercholesterolemia;Homozygous Familial HypercholesterolemiaDrug: EzetimibeOrganon and CoNULLCompleted18 YearsN/AAll4105Philippines
4NCT00092833
(ClinicalTrials.gov)
July 200223/9/2004Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous SitosterolemiaHypercholesterolemia, Familial;Lipid Metabolism, Inborn ErrorsDrug: Comparator: ezetimibeOrganon and CoNULLTerminated8 YearsN/AAll49Phase 3United States
5NCT03885921
(ClinicalTrials.gov)
October 25, 200020/3/2019Safety and Tolerability Study of Ezetimibe (SCH 058235/MK-0653) Plus Atorvastatin or Simvastatin in Homozygous Familial Hypercholesterolemia (P01417/MK-0653-019)Long-Term, Open-Label, Safety and Tolerability Study of SCH 58235 in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial HypercholesterolemiaHypercholesterolemiaDrug: Ezetimibe;Drug: Atorvastatin;Drug: SimvastatinOrganon and CoNULLCompleted12 YearsN/AAll44Phase 3NULL
6NCT03884452
(ClinicalTrials.gov)
May 3, 20006/3/2019Ezetimibe (SCH 58235) Taken With Either Atorvastatin or Simvastatin in Participants With Familial Hypercholesterolemia (MK-0653-018)A Phase III Efficacy And Safety Study of Ezetimibe (SCH58235) 10 mg in Addition to Atorvastatin or Simvastatin in the Therapy of Homozygous Familial HypercholesterolemiaFamilial HypercholesterolemiaDrug: Atorvastatin;Drug: Simvastatin;Drug: Ezetimibe;Drug: Placebo for EzetimibeOrganon and CoNULLCompleted12 YearsN/AAll50Phase 3NULL

93. Primary biliary cholangitis


Clinical trials : 298 Drugs : 252 - (DrugBank : 59) / Drug target genes : 35 - Drug target pathways : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2006-006742-34-GB
(EUCTR)
20/12/200703/06/2007The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis.The effect of Ezetimibe or pyridoxine in Patients with Primary Biliary Cirrhosis. primary biliary cirrhosis
MedDRA version: 9.1;Level: LLT;Classification code 10036680;Term: Primary biliary cirrhosis
Trade Name: Ezetrol
Product Name: Ezetimibe
Product Code: EZT
INN or Proposed INN: EZETIMIBE
Trade Name: pyridoxine 10mg BP
Product Name: pyridoxine 10mg
Product Code: A11HA02
INN or Proposed INN: PYRIDOXINE
Barts and The London NHS TrustNULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom

260. Sitosterolemia


Clinical trials : 12 Drugs : 11 - (DrugBank : 3) / Drug target gene : 1 - Drug target pathway : 1
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01584206
(ClinicalTrials.gov)
April 201216/4/2012Sitosterolemia MetabolismAssessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With EzetimibeSitosterolemiaDrug: EzetimibeUniversity of ManitobaNULLCompleted16 Years99 YearsAll8N/ACanada
2NCT00705211
(ClinicalTrials.gov)
June 200723/6/2008A 52-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05245)Designated Drug Use Investigation (Long-Term Administration) of Zetia 10-mg Tablets - A 52-Week Long-Term Designated Drug Use Investigation of Zetia Monotherapy and Combination TherapyHypercholesterolemia;Familial Hypercholesterolemia;Homozygous SitosterolemiaDrug: Ezetimibe;Drug: Ezetimibe + other lipid-lowering medication(s)Organon and CoBayerCompletedN/AN/AAll1794NULL
3NCT00704444
(ClinicalTrials.gov)
June 200723/6/2008A 12-week Post-marketing, Observational Study to Confirm the Safety and Efficacy of Zetia Alone or in Combination With Other Lipid-lowering Drugs in Japanese Subjects With Hypercholesterolemia (Study P05244)Designated Drug Use Investigation (12 Weeks) of Zetia 10mg Tablets - A 12-Week Designated Drug Use Investigation of Zetia Monotherapy and Combination TherapyHypercholesterolemia;Familial Hypercholesterolemia;Homozygous SitosterolemiaDrug: Ezetimibe;Drug: Ezetimibe + other lipid-lowering medication(s)Organon and CoBayerCompletedN/AN/AAll11332NULL
4EUCTR2004-001580-22-DE
(EUCTR)
21/12/200420/10/2004A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose StudyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study Homozygous SitosterolemiaTrade Name: Ezetrol
Product Name: Ezetrol
Product Code: MK-0653
MSD SHARP & DOHME GMBHNULLNot RecruitingFemale: yes
Male: yes
30Germany;United Kingdom
5EUCTR2004-001580-22-GB
(EUCTR)
16/12/200424/02/2005A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose StudyA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to an Ongoing Regimen of Ezetimibe 10 mg in Patients With Homozygous Sitosterolemia - Sitosterolemia High Dose Study Homozygous SitosterolemiaTrade Name: Ezetrol
Product Name: Ezetrol
Product Code: MK-0653
Merck Sharp & Dohme LtdNULLNot RecruitingFemale: yes
Male: yes
30Germany;United Kingdom
6NCT00099996
(ClinicalTrials.gov)
December 200421/12/2004Higher-Dose Ezetimibe to Treat Homozygous SitosterolemiaA Study to Assess Adding Ezetimibe 30 mg to Ongoing Treatment With Ezetimibe 10 mg in Patients With Homozygous SitosterolemiaHeart Diseases;Metabolism, Inborn ErrorsDrug: SCH-58235;Drug: EzetimibeNational Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth3Phase 3United States
7NCT00092898
(ClinicalTrials.gov)
October 200423/9/2004An Investigational Drug Study to Lower Non-Cholesterol Sterol Levels Associated With Sitosterolemia (0653-062)(COMPLETED)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Adding Ezetimibe 30 mg to An Ongoing Regimen of Ezetimibe 10 mg in Patients Homozygous SitosterolemiaLipid Metabolism, Inborn Errors;Heart DiseaseDrug: MK0653, ezetimibe;Drug: Comparator: placeboOrganon and CoNULLCompleted18 Years85 YearsAll30Phase 3United States
8NCT00092833
(ClinicalTrials.gov)
July 200223/9/2004Investigational Drug in Patients With Hypercholesterolemia or in Patients With Sitosterolemia (0653-026)(COMPLETED)An Open-Label, Worldwide, Treatment Use Study to Provide Ezetimibe 10 Mg/Day to Patients With Homozygous Familial Hypercholesterolemia or Homozygous SitosterolemiaHypercholesterolemia, Familial;Lipid Metabolism, Inborn ErrorsDrug: Comparator: ezetimibeOrganon and CoNULLTerminated8 YearsN/AAll49Phase 3United States
9NCT00045812
(ClinicalTrials.gov)
March 200110/9/2002SCH-58235 (Ezetimibe) to Treat Homozygous SitosterolemiaA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate SCH-58235 in Homozygous SitosterolemiaLipoidosisDrug: SCH-58235National Heart, Lung, and Blood Institute (NHLBI)NULLCompletedN/AN/ABoth5Phase 2United States
10NCT00092807
(ClinicalTrials.gov)
February 12, 200123/9/2004Sitosterolemia Extension Study (0653-003)(COMPLETED)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous Sitosterolemia - 1 Year Open-Label ExtensionLipid Metabolism, Inborn Errors;Heart DiseaseDrug: MK0653, ezetimibe;Drug: Comparator: placeboOrganon and CoNULLCompleted10 YearsN/AAll37Phase 3United States
11NCT00092820
(ClinicalTrials.gov)
February 12, 200123/9/2004Sitosterolemia Extension Study (0653-004)(COMPLETED)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MK0653 When Added to Current Regimen in Patients With Homozygous SitosterolemiaLipid Metabolism, Inborn Errors;Heart DiseaseDrug: MK0653, ezetimibe;Drug: Comparator: placeboOrganon and CoNULLCompleted10 YearsN/AAll58Phase 3NULL