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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2005-001033-15 |
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The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 2 mg | Experimental | Pitavastatin 2 mg once daily |
|
| Simvastatin 20 mg | Active Comparator | Simvastatin 20 mg once daily |
|
| Pitavastatin 4 mg | Experimental | Pitavastatin 4 mg once daily |
|
| Simvastatin 40 mg | Active Comparator | Simvastatn 40 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Low Density Lipoprotein-cholesterol (LDL-C) at 12 Weeks | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| National Cholesterol Education Program (NCEP) LDL-C Target Attainment | Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12 | 12 week |
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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 |
|---|---|---|---|---|---|---|
| Geri-Med Oy | Helsinki | Finland | ||||
| Kaisaniemen Laakariasema |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19785568 | Derived | Ose L, Budinski D, Hounslow N, Arneson V. Comparison of pitavastatin with simvastatin in primary hypercholesterolaemia or combined dyslipidaemia. Curr Med Res Opin. 2009 Nov;25(11):2755-64. doi: 10.1185/03007990903290886. |
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After a 6-8 week run in period when no lipid lowering therapy was allowed, subjects were randomized to one of 4 treatment arms.
Subjects were randomized to one of 4 treatment arms based on inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 2 mg | Pitavastatin 2 mg once daily |
| FG001 | Simvastatin 20 mg | Simvastatin 20 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Simvastatin |
| Drug |
Simvastatin once daily |
|
| Helsinki |
| Finland |
| Keravan Laakarikeskus | Helsinki | Finland |
| SOK-tyoterveyshuolto | Tampere | Finland |
| TYKS University Hospital | Turku | Finland |
| 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 |
| Volvat Medisinske Senter | Fredrikstad | Norway |
| Nyomen Legekontor | Kongsberg | Norway |
| Radhuset Spesialistsenter | Oslo | Norway |
| Rikshospitalet - University Hospital | Oslo | Norway |
| Skedsmo Medisinske Senter A.S. | Skedsmokorset | Norway |
| 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 |
| Moscow City Clinical Hospital 68 | 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 Michael's Partnership | Bath | United Kingdom |
| Avondale Surgery | Chesterfield | United Kingdom |
| Knowle House Surgery | Plymouth | United Kingdom |
| The Burngreave Surgery | Sheffield | United Kingdom |
| St Helier Hospital | Surrey | United Kingdom |
| Box Surgery | Wiltshire | United Kingdom |
| Eastleigh Surgery | Wiltshire | United Kingdom |
| Lovemead Group Practice | Wiltshire | United Kingdom |
| St Chad's Surgery | Wiltshire | United Kingdom |
| The Health Centre | Wiltshire | United Kingdom |
| FG002 |
| Pitavastatin 4 mg |
Pitavastatin 4 mg once daily |
| FG003 | Simvastatin 40 mg | Simvastatn 40 mg once daily |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 2 mg | Pitavastatin 2 mg once daily |
| BG001 | Simvastatin 20 mg | Simvastatin 20 mg once daily |
| BG002 | Pitavastatin 4 mg | Pitavastatin 4 mg once daily |
| BG003 | Simvastatin 40 mg | Simvastatn 40 mg once daily |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Data presented are for the safety population, defined as all randomized patients who receive at least one dose of the study drug. | Count of Participants | Participants |
| |||||||||||||||
| Age Continuous | Data presented are for the safety population, defined as all randomized patients who receive at least one dose of the study drug. | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Data presented are for the safety population, defined as all randomized patients who receive at least one dose of the study drug. | 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) at 12 Weeks | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C)after 12 Weeks | Posted | Mean | Standard Deviation | Percent change | Baseline to 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | National Cholesterol Education Program (NCEP) LDL-C Target Attainment | Number of subjects achieving National Cholesterol Education Program (NCEP) LDL-C Target (LDL less than or equal to 130 mg/dL)at Week 12 | Full Analysis Set | Posted | Number | Participants | 12 week |
|
|
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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 2 mg | Pitavastatin 2 mg once daily | 3 | 311 | 56 | 311 | ||
| EG001 | Simvastatin 20 mg | Simvastatin 20 mg once daily | 2 | 107 | 28 | 107 | ||
| EG002 | Pitavastatin 4 mg | Pitavastatin 4 mg once daily | 4 | 320 | 44 | 320 | ||
| EG003 | Simvastatin 40 mg | Simvastatn 40 mg once daily | 2 | 110 | 10 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pleuropericarditis | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Anaphylactic reation | Immune system disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Campylobacter intestinal infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system 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 |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Hounslow | Kowa Research Europe, Ltd. | 01189229004 | nhounslow@kowa.co.uk |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
|
|