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The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4 mg QD | Experimental | Pitavastatin 4 mg once daily |
|
| Atorvastatin 20 mg QD | Active Comparator | Atorvastatin 20 mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin 4 mg QD |
| |
| Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) | Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target | Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dragos Budinski, Med Dr. | Kowa Research Europe | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCBR Aalborg | Aalborg | Denmark | ||||
| CCBR A/S |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily |
| FG001 | Atorvastatin 20 mg QD | Atorvastatin 20 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Atorvastatin 20 mg |
|
|
| Ballerup Municipality |
| Denmark |
| CCBR Vejle | Vejle | Denmark |
| Gemeinschaftspraxis am Bahnhof | Berlin-Spandau | Germany |
| Pharmakologisches Studienzentum Chemnitz | Chemnitz | Germany |
| Internistische Diabetische Schwerpunktpraxis Dr. | Frankfurt am Main | Germany |
| Internistische Gemeinschaftspraxis | Mainz | Germany |
| Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler | Messkirch | Germany |
| Bhagwan Mahaveer Jain Heart Centre | Bangalore | India |
| Sri Ramachandra Medical College Hospital | Chennai | India |
| Apollo Hospitals | Hyderabaad | India |
| CARE Group of Hospitals | Hyderabaad | India |
| PD Hinduja Hospital | Mumbai | India |
| Andromed Breda | Breda | Netherlands |
| Andromed Eindhoven | Eindhoven | Netherlands |
| Andromed Noord | Groningen | Netherlands |
| Andromed Leiden | Leiden | Netherlands |
| Andromed Nijmegen | Nijmegen | Netherlands |
| Andromed Rotterdam | Rotterdam | Netherlands |
| Andromed Oost | Velp | Netherlands |
| Andromed Zoetermeer | Zoetermeer | Netherlands |
| 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 |
| Synexus Reading Clinical Research Centre | Berkshire | United Kingdom |
| Synexus Lancashire Clinical Research Centre | Lancashire | United Kingdom |
| Synexus Merseyside Clinical Research Centre | Liverpool | United Kingdom |
| Synexus Manchester Clinical Research Centre | Manchester | United Kingdom |
| Safety Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg QD | Pitavastatin 4 mg once daily |
| BG001 | Atorvastatin 20 mg QD | Atorvastatin 20 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 Low Density Lipoprotein Cholesterol (LDL-C) | Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C) | Posted | Aug 2009 | Mean | Standard Deviation | percent change | 12 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target | Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks | 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 | 29 | ||||
| EG001 | Atorvastatin 20 mg QD | Atorvastatin 20 mg once daily | 4 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Tachycardia paroxysmal | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue 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 Inc | 919 433 1600 | barana@kowaus.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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| >=65 years |
|
| Male |
|
|