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

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ClinicalTrials.gov Identifier: NCT01032993
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain Weakness Cramps Myalgia or Myositis Nos HMG COA Reductase Inhibitor Adverse Reaction Dietary Supplement: Coenzyme Q10 Other: Placebo Phase 2 Phase 3

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
Study Start Date : December 2009
Primary Completion Date : May 2016
Study Completion Date : May 2016

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Coenzyme Q10
600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily. Study wafers: ChewQ (Tishcon Corp, Westbury, NY) are chewable wafers each containing 100 mg of Coenzyme Q10 (ubidecarenone USP). All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Dietary Supplement: Coenzyme Q10
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
Placebo Comparator: Placebo
Placebo was manufactured by the manufacturer of ChewQ, Tishcon Corp (Westbury, NY), included the same excipients, but no active CoQ10, and looked and tasted identical to active agent. All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Other: Placebo
Placebo (three chewable tablets) 2 times daily for 4 weeks

Outcome Measures

Primary Outcome Measures :
  1. Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use [ Time Frame: 4 weeks ]
    Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10

Secondary Outcome Measures :
  1. Continuation of Statin [ Time Frame: 4 weeks ]
    Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.

  2. Percentage of Participants With Improvement in Disability Related to Muscle Pain [ Time Frame: 4 weeks ]
    Disability improvement was based on patient report of improvement they felt was meaningful to them

  3. Percentage of Participants With Adverse Effects [ Time Frame: 4 weeks ]
    serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.

Eligibility Criteria

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032993

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Catherine Buettner
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Catherine Buettner, MD, MPH Beth Israel Deaconess Medical Center
More Information

Responsible Party: Catherine Buettner, Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01032993     History of Changes
Other Study ID Numbers: K23AR055664 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2009    Key Record Dates
Results First Posted: January 23, 2017
Last Update Posted: January 23, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No consent for sharing IPD from trial participants was obtained when this clinical trial began

Keywords provided by Catherine Buettner, Beth Israel Deaconess Medical Center:
Muscle Pain
Muscle Weakness

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Pain
Neurologic Manifestations
Signs and Symptoms
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coenzyme Q10
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Growth Substances
Physiological Effects of Drugs