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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-001112-41 |
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This study is a long-term follow-up protocol for patients who participated in study NK-104-3.01EU or study NK-104-3.02EU.
Patients from the NK-104-3.01EU and NK-104-3.02EU studies will continue to receive either pitavastatin or the comparator statin for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4 mg QD | Experimental | Pitavastatin 4 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin 4 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) | Baseline to 52 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Cholesterol | Mean percent change from baseline in total cholesterol | Baseline to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dragos Budinski, Med Dr. | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Copenhagen | Denmark | ||||
| Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20080236 | Derived | Ose L, Budinski D, Hounslow N, Arneson V. Long-term treatment with pitavastatin is effective and well tolerated by patients with primary hypercholesterolemia or combined dyslipidemia. Atherosclerosis. 2010 May;210(1):202-8. doi: 10.1016/j.atherosclerosis.2009.12.009. Epub 2009 Dec 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Copenhagen |
| Denmark |
| Y Forskning, Bispebjerg Hospital | Copenhagen Nv | Denmark |
| Frederiks Hospital, Kardiologisk | Frederiksberg | Denmark |
| Kolesterollaboratoriet | Hellerup | Denmark |
| CCBR A/S | Vejle | Denmark |
| Geri-Med Oy | Helsinki | Finland |
| Kaisaniemen Laakariasema | Helsinki | Finland |
| Keravan Laakarikeskus | Helsinki | Finland |
| SOK-Tyoterveyshuolto | Tampere | Finland |
| TYKS University Hospital | Turku | Finland |
| Kardiologische Gemeinschaftspraxis Prof. Reifart | Bad Soden/Taunus | Germany |
| Praxis Dr. Boenninghoff | Beckum | Germany |
| Klinische Forschung Berlin Mitte | Berlin | Germany |
| Gemeinschaftspraxis am Bahnhof | Berlin-Spandau | Germany |
| Pharmakologisches Studienzentum Chemnitz | Chemnitz | Germany |
| GWT-TUK mbH, Zentrum fur Klinische Studien | Dresden | Germany |
| Internistische Diabetische Schwerpunktpraxis Dr. | Frankfurt am Main | Germany |
| Gemeinschaftspraxis Dr. Krause, Th. Menke | Goch | Germany |
| Klinische Forschung Hamburg | Hamburg | Germany |
| Innere Medizin I/Medizinische Klinik | Heidelberg | Germany |
| Gemeinschaftspraxis H. Holz Dr. Med, K. W. Klingl | Lampertheim | Germany |
| ZET-Studien GmbH Leipzig | Leipzig | Germany |
| Internistische Gemeinschaftspraxis | Mainz | Germany |
| Praxis Dr. Wachter | Mannheim | Germany |
| Gemeinschaftspraxis Melcherstaette | Melcherstaette | Germany |
| Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler | Messkirch | Germany |
| Praxisgemeinschaft im Kleinen Biergrund | Offenbach/M | Germany |
| Gemeinschaftspraxis Drs. Mockesch | Weinheim | Germany |
| Intermed Institud fur Klinische Forschung und Arzn | Wiesbaden | Germany |
| Gemeinschaftspraxis Dr. Emden, Frank Drewes | Worpswede | Germany |
| Care Hospital | Andhra Pradesh | 500034 | India |
| School of Diabetology, Nizam Institute of Medical Sciences | Andhra Pradesh | 500082 | India |
| Bhagwan Mahaveer Jain Heart Centre | Bangalore | India |
| Sri Ramachandra Medical College Hospital | Chennai | India |
| Heart Care Clinic | Gujarat | 380054 | India |
| Apollo Hospitals | Hyderabad | India |
| CARE Group of Hospitals | Hyderabad | India |
| St. John's Medical College Hospital | Karnataka | 560034 | India |
| Bathia Hospital | Maharashtra | 400007 | India |
| LTMMC & General Hospital | Maharashtra | 400022 | India |
| Sir J. J. Group of Hospitals | Maharashtra | 400027 | India |
| King Edward Medical College & Hospital | Maharashtra | 411001 | India |
| Ruby Hall Clinic | Maharashtra | 411001 | India |
| Lokmanya Hospital | Maharashtra | 411033 | India |
| PD Hinduja Hospital | Mumbai | India |
| Sir Gagaram Hospital | New Delhi | 110060 | India |
| Apollo Hospital | Tamil Nadu | 600006 | India |
| Department of Cardiology | Tamil Nadu | 641004 | India |
| Department of Internal Medicine, Soroka Medical Center | Beersheva | Israel |
| Department of Internal Medicine A, Rambal Medical Center | Haifa | Israel |
| Department of Internal Medicine, Wolfson Medical Center | Holon | Israel |
| Center for Research, Hadassah University Hospital | Jerusalem Ein Kerem | Israel |
| Meir Hospital | Kfar Saba | Israel |
| Department of Medicine, Hadassah Medical Center | Mount Scopus Jerusalem | Israel |
| Department of Internal Medicine, Rivka Sieff Medical Center | Safed | Israel |
| Institute of Metabolic Diseases | Tel Aviv | Israel |
| Institute of Lipid & Atherosclerosis Research | Tel Litwinsky | Israel |
| Dipartimento di Medicina Clinica e Biotecnologia Applicata | Bologna | Italy |
| Centro di Ricerca Clinica | Chieti | Italy |
| Gerontologia e Geriatria - Universita degli Studi | Ferrara | Italy |
| Dipartimento di Medicina Interna DIMI | Genova | Italy |
| Universita di Modena e Reggio Emilia, Policlinico | Modena | Italy |
| Dipartimento di Medicina Clinica e Sperimentale | Naples | Italy |
| Medicina Clinica e delle Patologie Emergenti | Palermo | Italy |
| Dipartimento di Medicina Interna e Scienze Biomediche | Parma | Italy |
| U.O. Malattie Metaboliche e Diabetologia | Treviglio | Italy |
| Azienda Ospedaliero-Universitaria | Trieste | Italy |
| Andromed Breda | Breda | Netherlands |
| Middellaan 5 | Breda | Netherlands |
| Andromed Eindhoven | Eindhoven | Netherlands |
| Bomanshof 8 | Eindhoven | Netherlands |
| Andromed Noord | Groningen | Netherlands |
| Damsterdiep 9 | Groningen | Netherlands |
| Vasculair Onderzoek Centrum Hoorn | Hoorn | Netherlands |
| Andromed Leiden | Leiden | Netherlands |
| Doezastraat 1 | Leiden | Netherlands |
| Andromed Nijmegen | Nijmegen | Netherlands |
| Kamerlingh Onnesstraat 16-18 | Nijmegen | Netherlands |
| Andromed Rotterdam | Rotterdam | Netherlands |
| Mathenesserlaan 247 | Rotterdam | Netherlands |
| Albert Schweitzer Ziekenhuis | Sliedrecht | Netherlands |
| Andromed Oost | Velp | Netherlands |
| Reigerstraat 30 | Velp | Netherlands |
| Rivierenland Tiel | Wp Tiel | Netherlands |
| Andromed Zoetermeer | Zoetermeer | Netherlands |
| Parkdreef 142 | Zoetermeer | Netherlands |
| Nyomen Legekontor | Kongsberg | Norway |
| Radhuset Spesialistsenter | Oslo | Norway |
| Rikshospitalet - University Hospital | Oslo | Norway |
| Skedsmo Medisinske Senter A.S. | Skedsmokorset | Norway |
| Podlaski Osrodek Kardiologii | Bialystok | Poland |
| NZOZ GCP Dobra Praktyka Lekaska | Gruziadz | Poland |
| NZOZ Terapia Optima | Katowice | Poland |
| NZOZ Centrum, Poradnia Kardiologiczna | Siedlce | Poland |
| Spec. Gab. Lek. Internistyczno-Kardiologicznly | Tarnów | Poland |
| Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego | Tychy | Poland |
| Instytut Zywnosci i Zywienia | Warsaw | Poland |
| Lecznica PROSEN SMO | Warsaw | Poland |
| Szpital Wolski,im. Dr A. Gostynskiej | Warsaw | Poland |
| NZOZ Esculap, Przychodnia Lekary Rodzinnych | Łosice | Poland |
| Kemerovo Cardiology Dispensary | Kemerovo | Russia |
| Central Clinical Hospital 1 of RZD | Moscow | Russia |
| City Clinical Hospital 23 | Moscow | Russia |
| City Clinical Hospital 64 | Moscow | Russia |
| Federal State Institution Out-Patient Clinic 3 of Russian Federation of President’s Management | Moscow | Russia |
| Moscow City Clinical Hospital 68 | Moscow | Russia |
| Moscow Regional Research Clinic Institute n.a.M.F.Vladimirov, Department of Therapy | Moscow | Russia |
| State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Development�, Department of Internal Diseases and Rheumatology based at City Clinica | Moscow | Russia |
| State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Development�, Hospital Therapy Department # 1 based at City Clinical Hospital # 40 | Moscow | Russia |
| State Educational Institution of Higher Professional Education “Moscow State University of Medicine and Dentistry of Federal Agency of Health Care and Social Development�, Hospital Therapy Department #1 based at City Clinical Hospital # 52 | Moscow | Russia |
| State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Development�, Department of Polyclinic Therapy based at Diagnostic Center # 1 | Moscow | Russia |
| State Educational Institution of Higher Professional Education “Russian State Medical University Federal Agency of Health Care and Social Development�, Department of Therapy based at City Hospital # 4 | Moscow | Russia |
| State Educational Institution of Higher Professional Education “Russian State Medical University of Federal Agency of Health Care and Social Development�, Department of Hospital Therapy #1 based at City Clinical Hospital #15, Cardiology Depar | Moscow | Russia |
| State Institution “Research Institute of Physical and Chemical Medicine� of Federal Agency of Health Care and Social Development, Laboratory of Clinical Cardiology based at Bauman City Hospital # 29 | Moscow | Russia |
| State Institution “Russian Cardiology Research Complex� of Federal Agency of Health Care and Social Development, Myasnikov Clinical Cardiology Institute, Department of Hemodialysis and Plasmapheresis | Moscow | Russia |
| State Research Center for Preventive Medicine | Moscow | Russia |
| Novosibirsk Reg. Clinical Cardiology Dispensary | Novosibirsk | Russia |
| Central Medical Unit 122, St. Pb | Saint Petersburg | Russia |
| Clinical Hospital of Russian Academy of Sciences | Saint Petersburg | Russia |
| Consulting and Diagnostic Center 85 | Saint Petersburg | Russia |
| Krestovsky Island Medical Institute | Saint Petersburg | Russia |
| Pokrovskaya City Hospital | Saint Petersburg | Russia |
| St. Petersburg State Medical Institution “Out-patient Clinic # 109� | Saint Petersburg | Russia |
| St.Petersburg State Medical Institution “Pokrovskaya City Hospital�, Cardiology Department #2 | Saint Petersburg | Russia |
| State Educational Institution of Higher Professional Education, “Saint-Petersburg State Medical University n.a.Academician I.P.Pavlov of Federal Agency of Health Care and Social Development�, Chair and Department of Faculty Therapy | Saint Petersburg | Russia |
| State Educational Institution of Higher Professional Education, “Saint-Petersburg State Medical University n.a.Academician I.P.Pavlov of Federal Agency of Health Care and Social Development�, Institute of Cardiovascular Diseases | Saint Petersburg | Russia |
| Hospital Clinico S. Juan de Alicante | San Juan | Alicante | Spain |
| Hospital Clinic i Provincial | Villaroel | Barcelona | Spain |
| Hospital de San Vicente | Alicante | 03690 | Spain |
| Hospital Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario de Bellvitge | Barcelona | Spain |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Hospital Ramon y Cajal | Madrid | 28000 | Spain |
| Centro de Especialidades Pedro Gonzalez Bueno | Madrid | 28037 | Spain |
| Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Centro de Salud de Ventanielles | Oviedo | 33010 | Spain |
| Hospital Marques de Valdecilla | Santander | 3908 | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | Spain |
| Hospital Virgen del Roci-o | Seville | 41013 | Spain |
| Hospital Dr. Peset | Valencia | 46017 | Spain |
| Hospital de Sagunto | Valencia | Spain |
| Hospital Clinico Lozano Blesa | Zaragoza | 50009 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| Angelholms Sjukhus, Medicinkliniken | Angelhom | Sweden |
| Sahlgrenska University Hospital, Intermedicin | Gothenburg | Sweden |
| Hjartmottagningen | Helsingborg | Sweden |
| Lakarcentrum Nyponet | Karineholm | Sweden |
| Medicinkliniken | Ludvika | Sweden |
| Huslakaren i Sandviken | Sandviken | Sweden |
| Narsjukhuset Sandviken, Kardiologlab, Medicin | Sandviken | Sweden |
| Hjart & Karlcenter | Södertälje | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | Sweden |
| Hjarthuset AB | Varberg | Sweden |
| Oldfield Surgery | Bath | United Kingdom |
| St James's Surgery | Bath | United Kingdom |
| St Michael's Partnership | Bath | United Kingdom |
| The Pulteney Practice | Bath | United Kingdom |
| Birmingham Clinical Research Centre | Birmingham | United Kingdom |
| Stonehill Medical Center | Bolton | United Kingdom |
| Avondale Surgery | Chesterfield | United Kingdom |
| Chorley Clinical Research Centre | Chorley | United Kingdom |
| Saltash Health Center | Cornwall | United Kingdom |
| Gomersal Lane Surgery | Dronfield | United Kingdom |
| Townhead Research | Irvine | United Kingdom |
| Crosby Clinical Research Centre | Liverpool | United Kingdom |
| The Symons Medical Center | Maidenhead | United Kingdom |
| Manchester Clinical Research Centre | Manchester | United Kingdom |
| Greenwood Medical Center | Nottingham | United Kingdom |
| Knowle House Surgery | Plymouth | United Kingdom |
| Reading Clinical Research Centre | Reading | United Kingdom |
| Elm Lane Surgery | Sheffield | United Kingdom |
| The Burngreave Surgery | Sheffield | United Kingdom |
| Brook Lane Surgery | Southampton | United Kingdom |
| St Helier Hospital | Surrey | United Kingdom |
| Box Surgery | Wiltshire | United Kingdom |
| Bradford Road Medical Center | Wiltshire | United Kingdom |
| Eastleigh Surgery | Wiltshire | United Kingdom |
| Lovemead Group Practice | Wiltshire | United Kingdom |
| Rowden Medical Partnership | Wiltshire | United Kingdom |
| St Chad's Surgery | Wiltshire | United Kingdom |
| The Health Centre | Wiltshire | United Kingdom |
| The Porch Surgery | Wiltshire | United Kingdom |
| The Burns Medical Practice | Yorkshire | United Kingdom |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) | Patients who had an observation at Week 52 | Posted | Aug 2009 | Mean | Standard Deviation | percent change | Baseline to 52 Weeks |
|
|
| ||||||||||||||||||||||||
| Secondary | Change From Baseline in Total Cholesterol | Mean percent change from baseline in total cholesterol | Patients who had an observation at Week 52 | Posted | Aug 2009 | Mean | Standard Deviation | percent change | Baseline to 52 weeks |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily | 49 | 1,353 | 293 | 1,353 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Osteomyelitis acute | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Fascitis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ovarian neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cranial neuropathy | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hypoxic encephalopathy | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ischaemic cerebral infarction | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Vascular encephalopathy | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bill Arana | Kowa Research Institute | 919 433 1600 | barana@kowaus.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C108475 | pitavastatin |
Not provided
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Not provided
| Denominators |
|---|
| Categories |
|---|
|