Back to resultsA Study Comparing CoQ10 Levels While Taking 3 Different Statins (SPARQ)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pitavastin 4mg
Atorvastatin 20mg
Rosuvastatin 5mg
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring LDL, HDL
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Pitavastatin 4mg
Atorvastatin 20mg
rosuvastatin 5 mg
Arm Description
Pitavastatin 4mg tablet by mouth once daily for 12 weeks
Atorvastatin 20mg tablet by mouth once daily for 12 weeks
rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
Outcomes
Primary Outcome Measures
Changes in Plasma CoQ10 Levels
Change in levels will be measured by taking difference between Baseline and Week 12 measures.
Secondary Outcome Measures
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.
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.
Changes in HDL and LDL Size
Change in levels will be measured by difference in levels at 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.
Changes HDL Particle Number and LDL Particle Number
Change in levels will be measured by difference in levels at 12 weeks.
Full Information
NCT ID
NCT01660191
First Posted
May 21, 2012
Last Updated
November 22, 2016
Sponsor
University of Kansas Medical Center
Collaborators
Kowa Pharmaceuticals America, Inc., Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT01660191
Brief Title
A Study Comparing CoQ10 Levels While Taking 3 Different Statins
Acronym
SPARQ
Official Title
A Study Comparing the Effects of Pitavastatin, Atorvastatin, and Rosuvastatin on Plasma Levels of CoQ10 (SPARQ)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Kowa Pharmaceuticals America, Inc., Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Pitavastatin lowers CoQ10 less than Atorvastatin or Rosuvastatin.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
LDL, HDL
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pitavastatin 4mg
Arm Type
Active Comparator
Arm Description
Pitavastatin 4mg tablet by mouth once daily for 12 weeks
Arm Title
Atorvastatin 20mg
Arm Type
Active Comparator
Arm Description
Atorvastatin 20mg tablet by mouth once daily for 12 weeks
Arm Title
rosuvastatin 5 mg
Arm Type
Active Comparator
Arm Description
rosuvastatin 5 mg tablet by mouth once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Pitavastin 4mg
Other Intervention Name(s)
Livalo
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 20mg
Other Intervention Name(s)
Lipitor
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin 5mg
Other Intervention Name(s)
Crestor
Primary Outcome Measure Information:
Title
Changes in Plasma CoQ10 Levels
Description
Change in levels will be measured by taking difference between Baseline and Week 12 measures.
Time Frame
Change from Baseline to 12 Weeks
Secondary Outcome Measure Information:
Title
Changes in Major Lipid Parameters - VLDL Size
Description
Change in levels will be measured by difference in levels at 12 weeks. Measure based on VLDL size.
Time Frame
Change from Baseline to 12 Weeks
Title
Changes to Glucose Metabolism - HbA1c and Insulin
Description
Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, and insulin.
Time Frame
Change from Baseline to 12 weeks
Title
Changes in HDL and LDL Size
Description
Change in levels will be measured by difference in levels at 12 weeks
Time Frame
Change from Baseline to 12 Weeks
Title
Changes to Glucose Metabolism - Fructosamine
Description
Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in fructosamine.
Time Frame
Change from Baseline to 12 weeks
Title
Changes HDL Particle Number and LDL Particle Number
Description
Change in levels will be measured by difference in levels at 12 weeks.
Time Frame
Change from Baseline to 12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick M Moriarty, MD, FACC
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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A Study Comparing CoQ10 Levels While Taking 3 Different Statins
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