A Study Comparing CoQ10 Levels While Taking 3 Different Statins

Study Overview
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Brief Summary
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The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.

Detailed Description
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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.

Official Title
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A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Pitavastin 4mg
* Drug: Atorvastatin 20mg
* Drug: Rosuvastatin 5mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LDL-C levels of 100-200mg/dl; triglycerides </=200mg/dl at screening visit Willing to discontinue use of all lipid-altering doses fo medication or supplements for the duration of the study Exclusion Criteria: LDL-C <100mg/dl or >200mg/dl, Triglycerides >200mg/dl History of diabetes mellitus or documented fasting blood glucose >125mg/dl or HbA1c >6.4% History of coronary artery disease history of chronic renal or hepatic disease known sensitivity of intolerance to a statin persistent elevated liver enzymes or CPK (>3 x upper normal limit) currently taking CoQ10 supplements and unable discontinue for duration of study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pitavastatin 4mg<br>Pitavastatin 4mg tablet by mouth once daily for 12 weeks | Drug: Atorvastatin 20mg<br> <br> * Other names: Lipitor;Drug: Rosuvastatin 5mg<br> <br> * Other names: Crestor;|
| Active Comparator: Atorvastatin 20mg<br>Atorvastatin 20mg tablet by mouth once daily for 12 weeks | Drug: Pitavastin 4mg<br> <br> * Other names: Livalo;Drug: Rosuvastatin 5mg<br> <br> * Other names: Crestor;|
| Active Comparator: rosuvastatin 5 mg<br>rosuvastatin 5 mg tablet by mouth once daily for 12 weeks | Drug: Pitavastin 4mg<br> <br> * Other names: Livalo;Drug: Atorvastatin 20mg<br> <br> * Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LDL, HDL