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This is a sixteen-week follow-on and 28 week single-blind extension study for patients who participated in study NK-104-304.
This is a sixteen-week, double-blind, active controlled, follow-on and 28 week single blind extension study for patients who participated in NK-104-304.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4 mg | Experimental | Pitavastatin 4 mg once daily |
|
| Simvastatin 40mg/80mg | Active Comparator | Simvastatin 40 mg or 80 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pitavastatin | Drug |
| ||
| simvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Attaining NCEP LDL-C Target at Week 16 | Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL. | 16 weeks |
| Number of Patients Attaining NCEP LDL-C Target at Week 44 | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL. | 44 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C | Baseline to 44 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dragos Budinski, MD | Kowa Research Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Y Forskning, Bispebjerg Hospital | Copenhagen Nv | Denmark | ||||
| Frederiks Hospital, Kardiologisk |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21874537 | Derived | Eriksson M, Budinski D, Hounslow N. Long-term efficacy of pitavastatin versus simvastatin. Adv Ther. 2011 Sep;28(9):799-810. doi: 10.1007/s12325-011-0057-6. Epub 2011 Aug 25. |
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Patients with primary hypercholesterolemia or combined dyslipidemia, who have satisfied the inclusion/exclusion criteria of the core study, and completed the core study were eligible for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4 mg | Ptavastatin 4 mg once daily |
| FG001 | Simvastatin 40mg/80mg | Simvastatin 40 mg or 80 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Frederiksberg |
| Denmark |
| Kolesterollaboratoriet | Hellerup | Denmark |
| CCBR A/S | Vejle | Denmark |
| Middellaan 5 | Breda | Netherlands |
| Bomanshof 8 | Eindhoven | Netherlands |
| Damsterdiep 9 | Groningen | Netherlands |
| Doezastraat 1 | Leiden | Netherlands |
| Kamerlingh Onnesstraat 16-18 | Nijmegen | Netherlands |
| Mathenesserlaan 247 | Rotterdam | Netherlands |
| Reigerstraat 30 | Velp | Netherlands |
| Parkdreef 142 | Zoetermeer | Netherlands |
| Hospital Clinico S. Juan de Alicante | San Juan | Alicante | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Hospital Ramon y Cajal | Madrid | 28000 | Spain |
| Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg | Ptavastatin 4 mg once daily |
| BG001 | Simvastatin 40mg/80mg | Simvastatin 40 mg or 80 mg once daily |
| BG002 | 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 | 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 | Number of Patients Attaining NCEP LDL-C Target at Week 16 | Number of patients attaining the National Cholesterol Education Program (NCEP) LDL-C target at Week 16. According to NCEP criteria the target LDL-C is 100 mg/dL. | All patients who received at least 1 dose of study drug and who had at least 1 on-treatment (post Visit 1) lipid assessment. | Posted | Sep 2009 | Number | particpants | 16 weeks |
|
|
| ||||||||||||||||||||||||||||
| Primary | Number of Patients Attaining NCEP LDL-C Target at Week 44 | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at Week 44. According to NCEP criteria the target LDL-C is 100 mg/dL. | Posted | Sep 2009 | Number | Participants | 44 Weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in LDL-C | Posted | Sep 2009 | Mean | Standard Deviation | percent change | Baseline to 44 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 | Ptavastatin 4 mg once daily | 4 | 121 | 57 | 121 | ||
| EG001 | Simvastatin 40mg/80mg | Simvastatin 40 mg or 80 mg once daily | 7 | 57 | 38 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Post cholecystectomy syndrome | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | Non-systematic Assessment |
| |
| Global amnesia | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | 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 |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bill Arana | Kowa Research Institute | 919 433-1600 | barana@kowaus.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular 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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| >=65 years |
|
| Male |
|
|
|