Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Pain, Weakness, Cramps, Myalgia or Myositis Nos, HMG COA Reductase Inhibitor Adverse Reaction

In brief

This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.

Key facts

Study ID

NCT01032993

Run by

Catherine Buettner

People needed

68

Starts

2009-12-01

Expected to finish

2016-05-01

Last updated by the study team

2017-01-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin

You may not qualify if…

• Plasma creatine kinase levels > 3 times the upper normal limit
• Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times the upper normal limit
• Pregnancy or breastfeeding (a contraindication for statin use)
• Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2
• Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3
• Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke
• Chest or abdominal surgery within the past six weeks
• Severe persistent pain related to other causes
• Unable to complete self-administered questionnaires, or unable to read or converse in English

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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