Suspended

Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia

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What is being tested

coenzyme Q10

+ matching placebo

Dietary Supplement
Who is being recruted

Muscular Diseases+7

+ Musculoskeletal Diseases

+ Nervous System Diseases

From 19 to 79 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2006
See protocol details

Summary

Principal SponsorCreighton University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2006

Actual date on which the first participant was enrolled.

Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.

Official TitleEfficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
NCT00590408
Principal SponsorCreighton University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 79 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainSigns and SymptomsPathological Conditions, Signs and SymptomsMusculoskeletal PainMyalgia

Criteria

1 inclusion criteria required to participate
Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level

6 exclusion criteria prevent from participating
Women of childbearing potential

Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)

Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins

Patients with a history of alcoholism or malnutrition

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The Cardiac Center of Creighton University Medical Center

Omaha, United StatesOpen The Cardiac Center of Creighton University Medical Center in Google Maps
SuspendedOne Study Center