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The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin in patients with risk factors for heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4 mg QD | Experimental | Pitavastatin 4 mg once daily |
|
| Simvastatin 40 mg QD | Active Comparator | Simvastatin 40 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pitavastatin | Drug |
| ||
| simvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL) | 12 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 |
|---|---|---|---|---|---|---|
| CCBR A/S | Aalborg | Denmark | ||||
| CCBR A/S |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21874538 | Derived | Eriksson M, Budinski D, Hounslow N. Comparative efficacy of pitavastatin and simvastatin in high-risk patients: a randomized controlled trial. Adv Ther. 2011 Sep;28(9):811-23. doi: 10.1007/s12325-011-0056-7. Epub 2011 Aug 25. |
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Patients who qualified entered a 6-8 week wash-out/dietary lead-in period followed by a 12- week treatment period. Patients were randomly assigned to one of the two treatment groups: pitavastatin 4 mg QD, or simvastatin 40 mg QD in a ratio of 2:1.
Subjects were enrolled from September 2005 to October 2006 at 43 investigator sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily |
| FG001 | Simvastatin 40 mg QD | Simvastatin 40 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Ballerup Municipality |
| Denmark |
| Y Forskning, Bispebjerg Hospital | Copenhagen NV | Denmark |
| Frederiks Hospital, Kardiologisk | 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 Clinic i Provincial | Villaroel | Barcelona | Spain |
| Hospital Universitario de Bellvitge | Barcelona | Spain |
| Hospital Vall d'Hebron | Barcelona | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Spain |
| Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Hospital Clinico Universitario de Santiago | Santiago de Compostela | Spain |
| Hospital de Sagunto | Valencia | Spain |
| Angelholms Sjukhus, Medicinkliniken | Angelhom | Sweden |
| Sahlgrenska University Hospital, Intermedicin | Gothenburg | Sweden |
| Hjartmottagningen | Helsingborg | Sweden |
| Lakarcentrum Nyponet | Karineholm | Sweden |
| Medicinkliniken | Ludvika | Sweden |
| Hjartmottagningen | Malmö | Sweden |
| Huslakaren i Sandviken | Sandviken | Sweden |
| Narsjukhuset Sandviken, Kardiologlab, Medicin | Sandviken | Sweden |
| Hjart & Karlcenter | Södertälje | Sweden |
| Karolinska Universitetssjukhuset | Stockholm | Sweden |
| Hjarthuset AB | Varberg | Sweden |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily |
| BG001 | Simvastatin 40 mg QD | Simvastatin 40 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 | Percent Change From Baseline in LDL-C | Percent change from baseline in low density lipoprotein-cholesterol (LDL-C) | Subjects who completed the treatment period | Posted | Aug 2009 | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients Attaining NCEP LDL-C Target (< 160 mg/dL) | Number of patients attaining LDL-C target according to National Cholesterol Education Program (NCEP) criteria (< 160 mg/dL) | Full analysis set (FAS) | Posted | Aug 2009 | Number | participants | 12 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 | 4 | 51 | ||||
| EG001 | Simvastatin 40 mg QD | Simvastatin 40 mg once daily | 5 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| cholelithiasis | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| peritonsilar abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Consitpation | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular 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 |
| 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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| >=65 years |
|
| Male |
|
|