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Completed

NCT Number: NCT01660191

A Study Comparing CoQ10 Levels While Taking 3 Different Statins

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

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pitavastin 4mg

Drug

Other names: Livalo

Atorvastatin 20mg

Drug

Other names: Lipitor

Rosuvastatin 5mg

Drug

Other names: Crestor

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Eli Lilly and Company
  • Kowa Pharmaceuticals America, Inc.

Registry information

Official study title

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

Acronym: SPARQ

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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