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| Name | Class |
|---|---|
| Kowa Pharmaceuticals America, Inc. | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.
Statins are known effectively treat high cholesterol and heart disease. However, statins may lower endogenous levels of Coenzyme10 (CoQ10). This decrease in CoQ10 levels may be responsible for side effects such as myalgia.
Previous studies have shown that Pitavastatin may not affect CoQ10 levels as other statins do, while still lowering cholesterol.
In this study, investigators intend to compare the plasma levels of CoQ10 in patients taking 3 different FDA-approved statins, in equipotent doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pitavastatin 4mg | Active Comparator | Pitavastatin 4mg tablet by mouth once daily for 12 weeks |
|
| Atorvastatin 20mg | Active Comparator | Atorvastatin 20mg tablet by mouth once daily for 12 weeks |
|
| rosuvastatin 5 mg | Active Comparator | rosuvastatin 5 mg tablet by mouth once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pitavastin 4mg | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Plasma CoQ10 Levels | Change in levels will be measured by taking difference between Baseline and Week 12 measures. | Change from Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Major Lipid Parameters - VLDL Size | Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size. | Change from Baseline to 12 Weeks |
| Changes to Glucose Metabolism - HbA1c and Insulin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick M Moriarty, MD, FACC | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atorvastatin 20mg | Atorvastatin 20mg, once daily by mouth for 12 weeks |
| FG001 | Pitavastatin 4mg | Pitavastatin 4mg, once daily by mouth for 12 weeks |
| FG002 | Rosuvastatin 5 mg | Rosuvastatin 5mg, once daily by mouth for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Enrollment and Washout |
| |||||||||||||
| Randomization |
| |||||||||||||
| End of Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Atorvastatin 20mg | Atorvastatin 20mg, once daily by mouth for 12 weeks |
| BG001 | Pitavastatin 4mg | Pitavastatin 4mg, once daily by mouth for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Changes in Plasma CoQ10 Levels | Change in levels will be measured by taking difference between Baseline and Week 12 measures. | Posted | Mean | Standard Deviation | μg/g | Change from Baseline to 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 | Atorvastatin 20mg | Atorvastatin 20mg, once daily by mouth for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie-Ann Dutton | University of Kansas Medical Center | 913-588-4064 | JDUTTON@kumc.edu |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C108475 | pitavastatin |
| D000069059 | Atorvastatin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin 20mg |
| Drug |
|
|
| Rosuvastatin 5mg | Drug |
|
|
Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
| Change from Baseline to 12 weeks |
| Changes in HDL and LDL Size | Change in levels will be measured by difference in levels at 12 weeks | Change from Baseline to 12 Weeks |
| Changes to Glucose Metabolism - Fructosamine | Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine. | Change from Baseline to 12 weeks |
| Changes HDL Particle Number and LDL Particle Number | Change in levels will be measured by difference in levels at 12 weeks. | Change from Baseline to 12 Weeks |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| BG002 | Rosuvastatin 5 mg | Rosuvastatin 5mg, once daily by mouth for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Waist Size | Mean | Standard Deviation | inches |
|
|
|
| Secondary | Changes in Major Lipid Parameters - VLDL Size | Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size. | Posted | Mean | Standard Deviation | nanometre (nm) | Change from Baseline to 12 Weeks |
|
|
|
| Secondary | Changes to Glucose Metabolism - HbA1c and Insulin | Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin. | Posted | Mean | Standard Deviation | percentage change from baseline measure | Change from Baseline to 12 weeks |
|
|
|
| Secondary | Changes in HDL and LDL Size | Change in levels will be measured by difference in levels at 12 weeks | Posted | Mean | Standard Deviation | nanometre (nm) | Change from Baseline to 12 Weeks |
|
|
|
| Secondary | Changes to Glucose Metabolism - Fructosamine | Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine. | Posted | Mean | Standard Deviation | µmol | Change from Baseline to 12 weeks |
|
|
|
| Secondary | Changes HDL Particle Number and LDL Particle Number | Change in levels will be measured by difference in levels at 12 weeks. | Posted | Mean | Standard Deviation | particle number | Change from Baseline to 12 Weeks |
|
|
|
| 0 |
| 45 |
| 1 |
| 45 |
| EG001 | Pitavastatin 4mg | Pitavastatin 4mg, once daily by mouth for 12 weeks | 0 | 45 | 2 | 45 |
| EG002 | Rosuvastatin 5 mg | Rosuvastatin 5mg, once daily by mouth for 12 weeks | 0 | 44 | 5 | 44 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
|
|
|