A Study Comparing CoQ10 Levels While Taking 3 Different Statins

NCT ID: NCT01660191

Last Updated: 2017-01-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pitavastatin 4mg

Pitavastatin 4mg tablet by mouth once daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Atorvastatin 20mg

Intervention Type DRUG

Rosuvastatin 5mg

Intervention Type DRUG

Atorvastatin 20mg

Atorvastatin 20mg tablet by mouth once daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Pitavastin 4mg

Intervention Type DRUG

Rosuvastatin 5mg

Intervention Type DRUG

rosuvastatin 5 mg

rosuvastatin 5 mg tablet by mouth once daily for 12 weeks

Group Type ACTIVE_COMPARATOR

Pitavastin 4mg

Intervention Type DRUG

Atorvastatin 20mg

Intervention Type DRUG

Interventions

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Pitavastin 4mg

Intervention Type DRUG

Atorvastatin 20mg

Intervention Type DRUG

Rosuvastatin 5mg

Intervention Type DRUG

Other Intervention Names

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Livalo Lipitor Crestor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kowa Pharmaceuticals America, Inc.

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Patrick Moriarty, MD, FACP, FACC

Director, Atherosclerosis & LDL-Apheresis Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick M Moriarty, MD, FACC

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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12943

Identifier Type: -

Identifier Source: org_study_id

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