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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01660191
Recruitment Status : Completed
First Posted : August 8, 2012
Results First Posted : January 18, 2017
Last Update Posted : January 18, 2017
Sponsor:
Collaborators:
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center

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

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Pitavastin 4mg Drug: Atorvastatin 20mg Drug: Rosuvastatin 5mg Phase 4

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 Design
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Kowa Pharmaceuticals America, Inc.
Eli Lilly and Company
Investigators
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Principal Investigator: Patrick M Moriarty, MD, FACC University of Kansas Medical Center
More Information
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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
Keywords provided by Patrick Moriarty, MD, FACP, FACC, University of Kansas Medical Center:
LDL, HDL
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin Calcium
Pitavastatin
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors