MedDataX Logo

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

NCT ID: NCT00590408

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Statin-associated Myalgia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

coenzyme Q10 statin myalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type ACTIVE_COMPARATOR

coenzyme Q10

Intervention Type DIETARY_SUPPLEMENT

60mg capsule twice daily for 12 weeks

2

Group Type PLACEBO_COMPARATOR

matching placebo

Intervention Type DIETARY_SUPPLEMENT

matching placebo capsule twice daily for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

coenzyme Q10

60mg capsule twice daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

matching placebo

matching placebo capsule twice daily for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level

Exclusion Criteria

* 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
* Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days
* Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.
Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Creighton University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Creighton University

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robyn Kondrack, PharmD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Cardiac Center of Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

05-13642

Identifier Type: -

Identifier Source: secondary_id

05-13642

Identifier Type: -

Identifier Source: org_study_id