This trial is active, not recruiting.

Conditions pain, weakness, cramps, myalgia, side effects of statins
Treatments coenzyme q10, placebo
Phase phase 2/phase 3
Sponsor Catherine Buettner
Collaborator National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Start date December 2009
End date October 2015
Trial size 50 participants
Trial identifier NCT01032993, K23 AR055664


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
coenzyme q10
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
(Placebo Comparator)
Placebo (three chewable tablets) 2 times daily for 4 weeks

Primary Outcomes

Muscle symptoms
time frame: 4 weeks

Secondary Outcomes

Continued statin use
time frame: 4 weeks
Muscle strength
time frame: 4 weeks
time frame: 4 weeks
Adverse effects
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Principal investigator Catherine Buettner, MD, MPH
Description This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.