{"id":"pitavastatin-nk-104","safety":{"commonSideEffects":[{"rate":"2-5","effect":"Muscle pain or myalgia"},{"rate":"1-3","effect":"Elevated liver enzymes (ALT/AST)"},{"rate":"2-4","effect":"Headache"},{"rate":"<0.1","effect":"Rhabdomyolysis"}]},"_chembl":{"chemblId":"CHEMBL1201753","moleculeType":"Small molecule","molecularWeight":"421.47"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a statin, pitavastatin competitively binds to HMG-CoA reductase and blocks the conversion of HMG-CoA to mevalonate, a critical early step in cholesterol biosynthesis. This leads to decreased intracellular cholesterol, upregulation of LDL receptors on hepatocytes, and enhanced clearance of LDL from the bloodstream. Pitavastatin is notable for its high selectivity for HMG-CoA reductase and favorable pharmacokinetic profile compared to other statins.","oneSentence":"Pitavastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:00:30.009Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Hypercholesterolemia and dyslipidemia"},{"name":"Primary prevention of cardiovascular disease"},{"name":"Secondary prevention of cardiovascular events in patients with established coronary artery disease"}]},"trialDetails":[{"nctId":"NCT07460960","phase":"PHASE2","title":"TRIal of STatin Therapy Effect on Androgen Status and Erectile functioN in Men","status":"RECRUITING","sponsor":"Lomonosov Moscow State University Medical Research and Educational Center","startDate":"2026-03-05","conditions":"Erectile Dysfunction Due to Arterial Disease, Atheroscleroses, Erectile Disfunction","enrollment":150},{"nctId":"NCT06982131","phase":"PHASE1","title":"A Study Investigating the Safety of RO7795081 and the Effect of RO7795081 on How the Body Processes Pitavastatin and Rosuvastatin in Otherwise Healthy Overweight or Obese Adult Participants","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2025-06-04","conditions":"Overweight, Obesity","enrollment":40},{"nctId":"NCT07445542","phase":"","title":"Efficacy and Safety of Pitavastatin/Ezetimibe After Switching From Statin Monotherapy to Pitavastatin/Ezetimibe in Patients With Hypercholesterolemia","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2021-12-18","conditions":"Hypercholesterolemia","enrollment":6927},{"nctId":"NCT07442630","phase":"PHASE4","title":"Long-term Comparison of Pitavastatin/Ezetimibe and Pitavastatin in Patients With Hypercholesterolemia and Elevated Triglycerides","status":"ACTIVE_NOT_RECRUITING","sponsor":"JW Pharmaceutical","startDate":"2023-08-21","conditions":"Hypercholesterolemia","enrollment":88},{"nctId":"NCT06553157","phase":"PHASE1, PHASE2","title":"Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy","status":"COMPLETED","sponsor":"Minia University","startDate":"2024-09-01","conditions":"Solid Tumors, Ototoxicity","enrollment":56},{"nctId":"NCT07351565","phase":"PHASE1","title":"Chemotherapy Plus Pitavastatin Guided by Patient-Derived Tumor-like Cell Clusters in Refractory Non-Small Cell Lung Cancer","status":"NOT_YET_RECRUITING","sponsor":"Chang Chen","startDate":"2026-01-10","conditions":"Non-Small Cell Lung Cancer","enrollment":22},{"nctId":"NCT07307989","phase":"PHASE2","title":"Early Statin-Ezetimibe Combination vs. Statin Monotherapy in Stroke With Atherosclerosis","status":"RECRUITING","sponsor":"Chang Gung Memorial Hospital","startDate":"2025-08-01","conditions":"Ischemic Stroke, Hypercholesteremia","enrollment":300},{"nctId":"NCT06501443","phase":"PHASE4","title":"LATAM LOWERS LDL-C","status":"RECRUITING","sponsor":"Novartis Pharmaceuticals","startDate":"2025-02-11","conditions":"Hypercholesterolaemia","enrollment":520},{"nctId":"NCT06317051","phase":"PHASE3","title":"Optimising Metabolic Management for People With Human Immunodeficiency Virus (HIV) on Integrase Based Antiretroviral Therapy (ART)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Kirby Institute","startDate":"2024-12-16","conditions":"HIV Infections, Weight Gain","enrollment":300},{"nctId":"NCT06813924","phase":"PHASE1","title":"A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2025-02-06","conditions":"Healthy Volunteers Sickle Cell Disease, Thalassemia","enrollment":37},{"nctId":"NCT06314919","phase":"","title":"A Study to Evaluate the Efficacy and Safety of Fixed-Dose Combination of Pitavastatin/Ezetimib","status":"RECRUITING","sponsor":"Boryung Pharmaceutical Co., Ltd","startDate":"2024-03-15","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemia","enrollment":8606},{"nctId":"NCT04512105","phase":"PHASE1","title":"Pitavastatin in Combination With Venetoclax for Chronic Lymphocytic Leukemia or Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"University of California, Irvine","startDate":"2020-12-02","conditions":"Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, AML, Adult","enrollment":6},{"nctId":"NCT01764178","phase":"PHASE1","title":"To Evaluate the Safety and PK Characteristics in Healthy Volunteers-Livalozet","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2013-01-22","conditions":"Hyperlipidemia, Hypertension","enrollment":52},{"nctId":"NCT02344290","phase":"PHASE3","title":"Evaluating the Use of Pitavastatin to Reduce the Risk of Cardiovascular Disease in HIV-Infected Adults","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2015-03-26","conditions":"HIV, Cardiovascular Diseases","enrollment":7769},{"nctId":"NCT07083206","phase":"","title":"A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin/ Ezetimibe","status":"RECRUITING","sponsor":"Ahn-Gook Pharmaceuticals Co.,Ltd","startDate":"2025-07-29","conditions":"Hypercholesterolemia, Dyslipidemias","enrollment":4500},{"nctId":"NCT06722521","phase":"PHASE4","title":"GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification","status":"RECRUITING","sponsor":"Asan Medical Center","startDate":"2025-07-09","conditions":"Primary Prevention, Vascular Calcification","enrollment":7435},{"nctId":"NCT06767774","phase":"PHASE4","title":"Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus","status":"RECRUITING","sponsor":"Korea University Anam Hospital","startDate":"2025-04-25","conditions":"ASCVD, Diabetes, Statin","enrollment":2000},{"nctId":"NCT06808646","phase":"PHASE1","title":"A Study to Assess the Effect of Ceftobiprole on the PK of Pitavastatin and on Plasma Levels of Coproporphyrin","status":"COMPLETED","sponsor":"Basilea Pharmaceutica","startDate":"2025-01-17","conditions":"Drug-drug Interaction Study","enrollment":12},{"nctId":"NCT06858982","phase":"","title":"PMMHRI-Pitavastatin Registry","status":"RECRUITING","sponsor":"Polish Mother Memorial Hospital Research Institute","startDate":"2024-06-01","conditions":"Hypercholesterolemia","enrollment":500},{"nctId":"NCT02888327","phase":"PHASE1","title":"A Drug-Drug Interaction Study to Evaluate the Effect of AL-794 on the Pharmacokinetics of Oseltamivir and JNJ-63623872","status":"COMPLETED","sponsor":"Alios Biopharma Inc.","startDate":"2016-07-31","conditions":"Influenza in Humans","enrollment":68},{"nctId":"NCT05537948","phase":"PHASE4","title":"Efficacy and Safety of Pitavastatin and PCSK9 Inhibitors in Liver Transplant Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"National Medical Research Center for Therapy and Preventive Medicine","startDate":"2021-10-01","conditions":"Dyslipidemias, Hyperlipidemias, Liver Transplant Disorder","enrollment":59},{"nctId":"NCT03070223","phase":"PHASE3","title":"PREPARE (A5361s) Ancillary Study of REPRIEVE (A5332)","status":"COMPLETED","sponsor":"Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections","startDate":"2017-03-14","conditions":"HIV-1 Infection","enrollment":602},{"nctId":"NCT05977738","phase":"EARLY_PHASE1","title":"Repurposed Drugs in Research for Cancer Clinical Trials- Pitavastatin","status":"COMPLETED","sponsor":"C.Dirven","startDate":"2024-01-18","conditions":"Glioblastoma Multiforme, Adult, Recurrent Glioblastoma","enrollment":12},{"nctId":"NCT02956590","phase":"PHASE3","title":"Dyslipidemia of Obesity Intervention in Teens","status":"COMPLETED","sponsor":"Carelon Research","startDate":"2018-05-01","conditions":"Dyslipidemia, Obesity","enrollment":122},{"nctId":"NCT05285085","phase":"","title":"Real World Evidence Study of Statin Use in Brazil","status":"COMPLETED","sponsor":"Hospital Israelita Albert Einstein","startDate":"2021-11-19","conditions":"Cardiovascular Diseases, Myocardial Infarction, Stroke","enrollment":2133900},{"nctId":"NCT06359353","phase":"PHASE4","title":"Effect of Pitavastatin on Bone","status":"COMPLETED","sponsor":"Seoul National University Bundang Hospital","startDate":"2019-04-08","conditions":"Osteoporosis, Osteopenia, Hypercholesterolemia, Menopausal Osteoporosis","enrollment":70},{"nctId":"NCT06273215","phase":"PHASE4","title":"Evaluation of the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Diabetic Patients","status":"UNKNOWN","sponsor":"Peking University Third Hospital","startDate":"2023-03-05","conditions":"Diabetes","enrollment":48},{"nctId":"NCT06262685","phase":"PHASE4","title":"Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins","status":"UNKNOWN","sponsor":"Instituto de Investigación Hospital Universitario La Paz","startDate":"2024-03-04","conditions":"Cardiovascular Diseases, Dyslipidemias, Statin Adverse Reaction","enrollment":216},{"nctId":"NCT06001047","phase":"NA","title":"Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV","status":"RECRUITING","sponsor":"Xi'an No.3 Hospital","startDate":"2023-11-01","conditions":"Benign Paroxysmal Positional Vertigo","enrollment":120},{"nctId":"NCT04289649","phase":"PHASE3","title":"K-924 Phase III Confirmatory Study","status":"COMPLETED","sponsor":"Kowa Company, Ltd.","startDate":"2020-04-02","conditions":"Hypercholesterolemia","enrollment":293},{"nctId":"NCT04289662","phase":"PHASE3","title":"K-924 Phase III Long Term Study","status":"COMPLETED","sponsor":"Kowa Company, Ltd.","startDate":"2020-03-23","conditions":"Hypercholesterolemia","enrollment":110},{"nctId":"NCT06096909","phase":"NA","title":"Early Initiation of Tafolecimab for Patients With Acute Coronary Syndromeundergoing Percutaneous Coronary Intervention in Chinese Population","status":"NOT_YET_RECRUITING","sponsor":"China National Center for Cardiovascular Diseases","startDate":"2023-11-01","conditions":"Acute Coronary Syndrome, Non ST Segment Elevation Acute Coronary Syndrome","enrollment":3684},{"nctId":"NCT00242944","phase":"PHASE4","title":"Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome (JAPAN-ACS)","status":"COMPLETED","sponsor":"Kyoto University","startDate":"2005-11","conditions":"Coronary Disease, Hypercholesterolemia","enrollment":307},{"nctId":"NCT01710007","phase":"PHASE3","title":"Efficacy and Safety Study of Pitavastatin for Hypercholesterolemia","status":"COMPLETED","sponsor":"Orient Pharma Co., Ltd.","startDate":"2011-11","conditions":"Hypercholesterolemia","enrollment":202},{"nctId":"NCT05705804","phase":"NA","title":"Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial","status":"UNKNOWN","sponsor":"Yonsei University","startDate":"2023-06-13","conditions":"Dyslipidemias, Atherosclerotic Cardiovascular Disease","enrollment":250},{"nctId":"NCT05747768","phase":"PHASE4","title":"A Clinical Study to Evaluate the Pharmacokinetics of Microdose Midazolam, Dabigatran, Pitavastatin, Atorvastatin and Rosuvastatin in Healthy Volunteers and Renal Impairment Patients","status":"UNKNOWN","sponsor":"Peking University Third Hospital","startDate":"2022-07-15","conditions":"Chronic Kidney Disease","enrollment":60},{"nctId":"NCT05334108","phase":"PHASE1","title":"Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport","status":"COMPLETED","sponsor":"Emalex Biosciences Inc.","startDate":"2022-04-26","conditions":"Drug Interaction","enrollment":56},{"nctId":"NCT04643093","phase":"PHASE3","title":"Compare the Efficacy and Safety of 1PC111 With Pitavastatin and Ezetimibe in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Orient Pharma Co., Ltd.","startDate":"2020-08-01","conditions":"Primary Hypercholesterolemia, Mixed Dyslipidemias","enrollment":390},{"nctId":"NCT04945122","phase":"PHASE4","title":"Comparison of Atorvastatin and Pitavastatin on the Effect of HbA1c in AMI Patients With Abnormal Glucose Metabolism","status":"UNKNOWN","sponsor":"Chinese Academy of Medical Sciences, Fuwai Hospital","startDate":"2015-10-01","conditions":"Acute Myocardial Infarction, Glucose Metabolism Disorders","enrollment":900},{"nctId":"NCT01166633","phase":"PHASE4","title":"Efficacy and Safety Study of Pitavastatin Versus Atorvastatin to Treat Hypercholesterolemia","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2009-06","conditions":"Hypercholesterolemia","enrollment":200},{"nctId":"NCT00653913","phase":"PHASE1","title":"Evaluation of Potential for Drug Interaction Between SCH 58235 (Ezetimibe) and Pitavastatin (Study P03962)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-03","conditions":"Hypercholesterolemia","enrollment":18},{"nctId":"NCT04584736","phase":"PHASE3","title":"To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2019-06-11","conditions":"Primary Hypercholesterolemia","enrollment":283},{"nctId":"NCT02863185","phase":"PHASE4","title":"Effect of Pitavastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease","status":"COMPLETED","sponsor":"Dong-A University","startDate":"2016-05-01","conditions":"Chronic Kidney Disease","enrollment":45},{"nctId":"NCT00846118","phase":"NA","title":"Differential Intervention Trial by Standard Therapy Versus Pitavastatin in Patients With Chronic Hemodialysis (DIALYSIS)","status":"TERMINATED","sponsor":"Chieko Hamada","startDate":"2009-02-01","conditions":"Cardiovascular Disease","enrollment":905},{"nctId":"NCT01057433","phase":"PHASE4","title":"Drug-Drug Interaction of Lopinavir/Ritonavir on Pitavastatin","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2010-01","conditions":"Healthy Volunteers","enrollment":24},{"nctId":"NCT04764851","phase":"PHASE1","title":"Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates","status":"TERMINATED","sponsor":"Emalex Biosciences Inc.","startDate":"2021-02-18","conditions":"Drug-Interactions","enrollment":30},{"nctId":"NCT01042730","phase":"NA","title":"Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease (REAL-CAD)","status":"COMPLETED","sponsor":"Juntendo University","startDate":"2010-02","conditions":"Coronary Artery Disease","enrollment":13054},{"nctId":"NCT02799758","phase":"PHASE3","title":"Efficacy & Long-term Safety Comparison Study of NK-104-CR & Livalo® IR With Primary Hyperlipidemia or Mixed Dyslipidemia","status":"WITHDRAWN","sponsor":"Kowa Research Institute, Inc.","startDate":"2016-02","conditions":"Hyperlipidemia, Dyslipidemia","enrollment":""},{"nctId":"NCT02670434","phase":"PHASE3","title":"Safety and Efficacy Comparison Study of NK-104-CR (Controled Release) in Patients With Primary Hyperlipidemia or Mixed Dyslipidemia","status":"WITHDRAWN","sponsor":"Kowa Research Institute, Inc.","startDate":"2016-01","conditions":"Hyperlipidemia, Dyslipidemia","enrollment":""},{"nctId":"NCT04402112","phase":"","title":"Efficacy and Safety of Pitavastatin in a Real-world Setting","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2012-04-02","conditions":"Hypercholesterolemia","enrollment":28343},{"nctId":"NCT04270344","phase":"","title":"The Occurrence of MACE in Patients With AMI Receiving Pitavastatin/Valsartan Treatment","status":"UNKNOWN","sponsor":"JW Pharmaceutical","startDate":"2018-07-01","conditions":"Hypercholesterolemia","enrollment":905},{"nctId":"NCT04829149","phase":"","title":"Statin Monotherapy and Rosuzet Tab.(Rosuvastatin/Ezetimibe) Administration in Patients With Dyslipidemia in Korea","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2016-06-14","conditions":"Dyslipidemias","enrollment":5717},{"nctId":"NCT04705909","phase":"PHASE2, PHASE3","title":"Efficacy of Statin Addition to Neoadjuvant Chemotherapy Protocols for Breast Cancer","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2021-01-15","conditions":"Breast Cancer","enrollment":60},{"nctId":"NCT02545231","phase":"PHASE4","title":"Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis","status":"COMPLETED","sponsor":"Korea University Anam Hospital","startDate":"2013-02","conditions":"Atherosclerosis, Neointima, Angina","enrollment":1000},{"nctId":"NCT03730038","phase":"NA","title":"Effects of Pitavastatin Treatments on the Plasma Lgi3 Level in the Patients With Dyslipidemia","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2019-02-18","conditions":"Dyslipidemias","enrollment":50},{"nctId":"NCT01695954","phase":"PHASE1","title":"Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz","status":"COMPLETED","sponsor":"NYU Langone Health","startDate":"2012-05","conditions":"Hyperlipidemia, HIV","enrollment":34},{"nctId":"NCT03717064","phase":"PHASE1","title":"A Study to Investigate the Effect of RO7049389 on the Pharmacokinetics of Pitavastatin in Healthy Volunteers","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2018-11-07","conditions":"Healthy Volunteers","enrollment":18},{"nctId":"NCT03311841","phase":"PHASE1","title":"Pharmacokinetics of Midazolam, Dabigatran, Pitavastatin, Atorvastatin, and Rosuvastatin in Participants With Renal Insufficiency in the Presence and Absence of Rifampin (MK-0000-386)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-03-01","conditions":"Renal Insufficiency","enrollment":32},{"nctId":"NCT01890967","phase":"PHASE2","title":"A Study of LY3015014 in Participants With High Cholesterol","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2013-06","conditions":"Hypercholesterolemia","enrollment":527},{"nctId":"NCT00889226","phase":"PHASE4","title":"Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2008-04","conditions":"Hypercholesterolemia With Type2DM","enrollment":161},{"nctId":"NCT02743260","phase":"PHASE4","title":"Drug Transporter Interaction Study PHENTRA_2015_KPUK","status":"COMPLETED","sponsor":"University of Cologne","startDate":"2016-04","conditions":"Healthy","enrollment":24},{"nctId":"NCT04061824","phase":"PHASE4","title":"Clinical Study to Evaluate Adherence Improvement Fixed-dose Combination of Olostar Tab. in Patients With Hypertension and Dyslipidemia","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2016-05-24","conditions":"Hypertension, Dyslipidemias","enrollment":150},{"nctId":"NCT02290106","phase":"NA","title":"Effects of Pitavastatin on Insulin Sensitivity and Liver Fat","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2015-03-02","conditions":"Obesity, Fatty Liver, Nonalcoholic","enrollment":50},{"nctId":"NCT03532620","phase":"PHASE4","title":"China Protection Trial of Glucose Metabolism by Pitavastatin in Patients With Prediabetes and Hypertension","status":"UNKNOWN","sponsor":"Jun Tao","startDate":"2018-08-09","conditions":"Prediabetic State, Hypertension, Dyslipidemias","enrollment":396},{"nctId":"NCT03606824","phase":"NA","title":"Thyroid Hormone Replacement for Subclinical Hypothyroidism and Dyslipidemia in ASCVD (ThyroHeart-Lipid Study)","status":"UNKNOWN","sponsor":"Shaochun.Li","startDate":"2019-03-25","conditions":"Dyslipidemia, Subclinical hypothyroïdism, Statin","enrollment":248},{"nctId":"NCT00723398","phase":"NA","title":"Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention","status":"COMPLETED","sponsor":"Milton S. Hershey Medical Center","startDate":"2009-03","conditions":"Breast Cancer","enrollment":266},{"nctId":"NCT03618797","phase":"PHASE3","title":"A Clinical Trial to Evaluate the Efficacy and Safety of Pitavastatin/Fenofibrate in Complex-dyslipidemia","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2015-11","conditions":"Complex-dyslipidemia","enrollment":347},{"nctId":"NCT02250976","phase":"PHASE1","title":"The Pharmacokinetic Study of the Fixed-dose Combination of Micronized Fenofibrate and Pitavastatin Ca","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2014-09","conditions":"Healthy Male Volunteers","enrollment":41},{"nctId":"NCT01767610","phase":"PHASE1","title":"Evaluation of Pharmacokinetic Interaction Between Micronized Fenofibrate and Pitavastatin","status":"COMPLETED","sponsor":"Hanlim Pharm. Co., Ltd.","startDate":"2013-01","conditions":"Healthy Male Volunteers","enrollment":24},{"nctId":"NCT02056847","phase":"PHASE4","title":"to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2013-09","conditions":"HbA1c Level Associated With Lipid Compositions","enrollment":313},{"nctId":"NCT03418974","phase":"PHASE4","title":"Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia","status":"UNKNOWN","sponsor":"Fudan University","startDate":"2017-11-01","conditions":"Dyslipidemias","enrollment":10000},{"nctId":"NCT02940366","phase":"PHASE4","title":"Effect of High-dose Pitavastatin on Glucose Control in Patients With Metabolic Syndrome","status":"UNKNOWN","sponsor":"Seoul National University Hospital","startDate":"2016-12-01","conditions":"Metabolic Syndrome","enrollment":500},{"nctId":"NCT01660191","phase":"PHASE4","title":"A Study Comparing CoQ10 Levels While Taking 3 Different Statins","status":"COMPLETED","sponsor":"University of Kansas Medical Center","startDate":"2011-12","conditions":"Hypercholesterolemia","enrollment":134},{"nctId":"NCT02144922","phase":"PHASE4","title":"Effect of Pitavastatin on Coronary Flow Reserve in Hypertensive Patients","status":"COMPLETED","sponsor":"Asan Medical Center","startDate":"2014-05","conditions":"Hypertension, Cardiovascular Risk","enrollment":85},{"nctId":"NCT02442700","phase":"PHASE4","title":"Effects of Pitavastatin on Lipid Profiles in HIV-infected Patients With Dyslipidemia and Receiving Atazanavir/Ritonavir","status":"COMPLETED","sponsor":"Ramathibodi Hospital","startDate":"2014-05","conditions":"HIV, Dyslipidemia","enrollment":24},{"nctId":"NCT02107898","phase":"PHASE3","title":"Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy (ODYSSEY JAPAN)","status":"COMPLETED","sponsor":"Sanofi","startDate":"2014-03","conditions":"Hypercholesterolemia","enrollment":216},{"nctId":"NCT01502904","phase":"PHASE4","title":"Neointimal Coverage After Implantation of Biolimus Eluting Stent With Biodegradable Polymer: Optical Coherence Tomographic Assessment According to the Treatment of Dyslipidemia and Hypertension and the Types of Implanted Drug-eluting Stents","status":"COMPLETED","sponsor":"Yonsei University","startDate":"2010-07","conditions":"Stable Angina or Acute Coronary Syndrome Considered for Percutaneous Coronary Intervention With Dyslipidemia or Hypertension","enrollment":120},{"nctId":"NCT02595268","phase":"PHASE1","title":"A Study to Investigate the Effect of JNJ-63623872 on Pitavastatin in Healthy Participants","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2015-11","conditions":"Healthy","enrollment":14},{"nctId":"NCT02634034","phase":"PHASE1","title":"A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2015-12","conditions":"Hyperlipidemia","enrollment":18},{"nctId":"NCT01265706","phase":"","title":"Livalo Acute Myocardial Infarction Study (LAMIS)","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2010-07","conditions":"Acute Myocardial Infarction","enrollment":1000},{"nctId":"NCT00701285","phase":"PHASE4","title":"South Korean Pitavastatin Heart Failure Study","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2008-07","conditions":"Chronic Heart Failure","enrollment":70},{"nctId":"NCT01402843","phase":"PHASE3","title":"Efficacy, Safety of Coadministered Pitavastatin and Valsartan in Patients With Hypertension and Dyslipidemia","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2011-06","conditions":"Hypertension, Dyslipidemia","enrollment":150},{"nctId":"NCT01301066","phase":"PHASE4","title":"A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2010-12","conditions":"Dyslipidemia","enrollment":252},{"nctId":"NCT00861861","phase":"PHASE4","title":"Comparison of Pitavastatin With Atorvastatin in Increasing High Density Lipoprotein - Cholesterol (HDL-C) and Adiponectin in Patients With Dyslipidemia and Coronary Artery Disease (CAD)","status":"COMPLETED","sponsor":"Kumamoto University","startDate":"2008-09","conditions":"Hypercholesterolemia, Coronary Artery Disease","enrollment":129},{"nctId":"NCT00301392","phase":"PHASE4","title":"Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)","status":"COMPLETED","sponsor":"Tokyo University","startDate":"2006-04","conditions":"Diabetes Mellitus, Glucose Intolerance","enrollment":1240},{"nctId":"NCT01595828","phase":"PHASE1","title":"Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome","status":"COMPLETED","sponsor":"Kowa Research Europe","startDate":"2010-10","conditions":"Metabolic Syndrome","enrollment":14},{"nctId":"NCT01871792","phase":"PHASE4","title":"Preventive Effect of Pitavastatin on Contrast-Induced Nephropathy in Patients With Renal Dysfunction","status":"UNKNOWN","sponsor":"Gachon University Gil Medical Center","startDate":"2013-06","conditions":"Contrast-induced Nephropathy","enrollment":404},{"nctId":"NCT01648829","phase":"PHASE4","title":"PharmacOdynamic compaRison of piTavastatin Versus atOrvastatin on Platelet Reactivity","status":"UNKNOWN","sponsor":"University of Roma La Sapienza","startDate":"2014-01","conditions":"Coronary Artery Disease","enrollment":100},{"nctId":"NCT01406431","phase":"PHASE1","title":"Pharmacokinetic Study of Livalo® Fixed Combination Drug in Healthy Subjects","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2011-08","conditions":"Hyperlipidemia, Hypertension","enrollment":48},{"nctId":"NCT01178853","phase":"PHASE4","title":"Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2010-07","conditions":"Healthy","enrollment":48},{"nctId":"NCT01043094","phase":"PHASE4","title":"Safety, Tolerability, and Pharmacokinetic of Single Dose of Pitavastatin 4 mg in Severe Renal Patients Versus Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2009-12","conditions":"Severe Renal Impairment","enrollment":16},{"nctId":"NCT01422369","phase":"PHASE4","title":"Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2011-04","conditions":"Healthy","enrollment":28},{"nctId":"NCT01422382","phase":"PHASE4","title":"Drug-Drug Interaction of Cardizem LA (Diltiazem Hydrochloride) on Pitavastatin","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2011-05","conditions":"Healthy","enrollment":28},{"nctId":"NCT00548145","phase":"NA","title":"The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease","status":"TERMINATED","sponsor":"Osaka University","startDate":"2007-11","conditions":"Alzheimer Disease, Hypercholesterolemia","enrollment":38},{"nctId":"NCT01256476","phase":"PHASE4","title":"Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia","status":"COMPLETED","sponsor":"Kowa Research Institute, Inc.","startDate":"2010-10","conditions":"Primary Dyslipidemia, Mixed Dyslipidemia","enrollment":328},{"nctId":"NCT01223586","phase":"","title":"Extended Japan Assessment of Pitavastatin and Atorvastatin in Acute Coronary Syndrome","status":"COMPLETED","sponsor":"Kyoto University","startDate":"2010-11","conditions":"Statin, Coronary Plaque, Acute Coronary Syndrome","enrollment":238},{"nctId":"NCT00805714","phase":"","title":"Livalo Acute Myocardial Infarction Study","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2007-04","conditions":"Acute Myocardial Infarction","enrollment":1128},{"nctId":"NCT00786734","phase":"PHASE4","title":"Pitavastatin Pre-Treatment Study in Patient With Elective PCI for Stable Angina Pectoris (PIPA)","status":"WITHDRAWN","sponsor":"JW Pharmaceutical","startDate":"2008-08","conditions":"Percutaneous Coronary Intervention","enrollment":""},{"nctId":"NCT00640276","phase":"PHASE4","title":"Safety and Efficacy Study of Pitavastatin in Patient With a Metabolic Syndrome","status":"COMPLETED","sponsor":"JW Pharmaceutical","startDate":"2008-04","conditions":"Hypercholesterolemia, Metabolic Syndrome","enrollment":187},{"nctId":"NCT00716846","phase":"NA","title":"Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers","status":"COMPLETED","sponsor":"Hamamatsu University","startDate":"2006-06","conditions":"Healthy Volunteers","enrollment":11}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":40,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Livalo"],"phase":"marketed","status":"active","brandName":"Pitavastatin (NK-104)","genericName":"Pitavastatin (NK-104)","companyName":"Kowa Research Institute, Inc.","companyId":"kowa-research-institute-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Pitavastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels. Used for Hypercholesterolemia and dyslipidemia, Primary prevention of cardiovascular disease, Secondary prevention of cardiovascular events in patients with established coronary artery disease.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}