A Study Comparing CoQ10 Levels While Taking 3 Different Statins (SPARQ)
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ClinicalTrials.gov Identifier: NCT01660191 |
Recruitment Status :
Completed
First Posted : August 8, 2012
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypercholesterolemia | Drug: Pitavastin 4mg Drug: Atorvastatin 20mg Drug: Rosuvastatin 5mg | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 134 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ) |
Study Start Date : | December 2011 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | October 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Pitavastatin 4mg
Pitavastatin 4mg tablet by mouth once daily for 12 weeks
|
Drug: Atorvastatin 20mg
Other Name: Lipitor Drug: Rosuvastatin 5mg Other Name: Crestor |
Active Comparator: Atorvastatin 20mg
Atorvastatin 20mg tablet by mouth once daily for 12 weeks
|
Drug: Pitavastin 4mg
Other Name: Livalo Drug: Rosuvastatin 5mg Other Name: Crestor |
Active Comparator: rosuvastatin 5 mg
rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
|
Drug: Pitavastin 4mg
Other Name: Livalo Drug: Atorvastatin 20mg Other Name: Lipitor |
- Changes in Plasma CoQ10 Levels [ Time Frame: Change from Baseline to 12 Weeks ]Change in levels will be measured by taking difference between Baseline and Week 12 measures.
- Changes in Major Lipid Parameters - VLDL Size [ Time Frame: Change from Baseline to 12 Weeks ]Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.
- Changes to Glucose Metabolism - HbA1c and Insulin [ Time Frame: Change from Baseline to 12 weeks ]Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
- Changes in HDL and LDL Size [ Time Frame: Change from Baseline to 12 Weeks ]Change in levels will be measured by difference in levels at 12 weeks
- Changes to Glucose Metabolism - Fructosamine [ Time Frame: Change from Baseline to 12 weeks ]Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.
- Changes HDL Particle Number and LDL Particle Number [ Time Frame: Change from Baseline to 12 Weeks ]Change in levels will be measured by difference in levels at 12 weeks.

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660191
United States, Kansas | |
University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160 |
Principal Investigator: | Patrick M Moriarty, MD, FACC | University of Kansas Medical Center |
Responsible Party: | Patrick Moriarty, MD, FACP, FACC, Director, Atherosclerosis & LDL-Apheresis Center, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT01660191 |
Other Study ID Numbers: |
12943 |
First Posted: | August 8, 2012 Key Record Dates |
Results First Posted: | January 18, 2017 |
Last Update Posted: | January 18, 2017 |
Last Verified: | November 2016 |
LDL, HDL |
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Rosuvastatin Calcium |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |