A Study Comparing CoQ10 Levels While Taking 3 Different Statins (SPARQ)

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

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: Atorvastatin 20mg; Drug: Rosuvastatin 5mg; Drug: Pitavastin 4mg

Detailed Description

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
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Eli Lilly and Company; Kowa Pharmaceuticals America, Inc.
• Investigators: Principal Investigator: Patrick M Moriarty, MD, FACC, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 21, 2012
• First Submitted That Met QC Criteria: August 3, 2012
• First Posted (Estimate): August 8, 2012

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: LDL, HDL
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Rosuvastatin Calcium
• Other Study ID Numbers: 12943

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No