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This is a sixteen-week double-blind active-controlled follow-on and 28-week single-blind extension study for patients who participated in study NK-104-305.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin | Experimental | Pitavastatin 4 mg QD |
|
| Atorvastatin | Active Comparator | Atorvastatin 40 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastatin | Drug | Pitavastatin 4 mg QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| NCEP LDL-C Target Attainment | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study. | 44 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in LDL-C | Percent change from baseline in LDL-C at 44 weeks | Basseline to 44 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dragos Budinski, MD | Kowa Research Europe (KRE) | 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 | Pitavastatin 4 mg once daily |
| FG001 | Atorvastatin 40 mg | Atorvastatin 40 mg once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Atorvastatin | Drug | Atorvastatin 40 mg |
|
|
| Vejle |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pitavastatin 4 mg | Pitavastatin 4 mg once daily |
| BG001 | Atorvastatin 40 mg | Atorvastatin 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 |
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| 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 | NCEP LDL-C Target Attainment | Number of patients attaining National Cholesterol Education Program (NCEP) LDL-C target at 44 weeks. According to NCEP criteria the target LDL-C is 100 mg/dL for all patients in this study. | The efficacy population is defined as all patients who received at least one dose of study drug and who had at least one on-treatment lipid assessment | Posted | Sep 2009 | Number | Participants | 44 weeks |
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| ||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in LDL-C | Percent change from baseline in LDL-C at 44 weeks | Posted | Sep 2009 | Mean | Standard Deviation | percent change | Basseline 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 | Pitavastatin 4 mg once daily | 8 | 143 | 22 | 143 | ||
| EG001 | Atorvastatin 40 mg | Atorvastatin 40 mg once daily | 5 | 71 | 15 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Umbilical hernia, obstructive | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Bacterial pyelonephritis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 8.1 | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
| |
| Myalgia intercostal | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia/myalgia intercostal | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Naspopharyngitis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition 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 |
|---|---|
| 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 |
|
|