A Phase 4 interventional study of coenzyme Q10 and matching placebo in Statin-associated Myalgia, sponsored by Creighton University. Terminated at 1 site in United States. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2009-12-01.
Sponsored by Creighton University · Phase 4, Interventional, and Treatment
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.
282 studies on the registry are indexed under Myalgia; 43 are open to participants now.
This study's enrollment of 10 is below the median of 44 across 241 interventional studies indexed under Myalgia.
Browse Myalgia studies →Creighton University is the lead sponsor of 126 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Dietary Supplement: coenzyme Q10
Dietary Supplement: matching placebo
60mg capsule twice daily for 12 weeks
matching placebo capsule twice daily for 12 weeks
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Time frame: every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks
evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Time frame: every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks
This study is terminated, as verified in Nov 2009. You cannot join it, but the record below documents what was studied.
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Creighton University