A Study Comparing CoQ10 Levels While Taking 3 Different Statins

Hypercholesterolemia Clinical Trial

— SPARQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660191
• Other study ID #: 12943
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2012
• Last updated: February 3, 2014
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2014
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: October 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 blodo glucose >125mg/dl or HbA1c >6.4%

• History of coronary artery disease

• history of chrinic 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Statin
Pitavastatin 4mg, Atorvastatin 20mg, or rosuvastatin 5mg, once daily by mouth for 12 weeks

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Eli Lilly and Company, Kowa Pharmaceuticals America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma CoQ10 levels	Change in levels will be measured by levels at 12 weeks minus levels at baseline	Change from Baseline to 12 Weeks	No
Secondary	Changes in major lipid parameters	Change in levels will be measured by levels at 12 weeks minus levels at baseline. Major lipid parameters include apoA1, apoB, LDL and HDL particle number and size.	Change from Baseline to 12 Weeks	No
Secondary	Changes to glucose metabolism	Change in levels will be measured by levels at 12 weeks minus levels at baseline. Changes measured based in HbA1c, frusctosamine, insulin, and proinsulin.	Change from Baseline to 12 weeks	No