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

Last updated: November 29, 2016
Sponsor: Catherine Buettner
Overall Status: Completed

Phase

2/3

Condition

Pain

Pain (Pediatric)

Muscle Pain

Treatment

N/A

Clinical Study ID

NCT01032993
K23AR055664
K23AR055664
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Plasma creatine kinase levels > 3 times the upper normal limit

  • Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times theupper normal limit

  • Pregnancy or breastfeeding (a contraindication for statin use)

  • Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73m2

  • 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, unstableangina, or revascularization procedure within the past six weeks, a history of brainaneurysm 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 inEnglish

Study Design

Total Participants: 68
Study Start date:
December 01, 2009
Estimated Completion Date:
May 31, 2016

Study 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.

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

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