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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Catherine Buettner, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01032993
First received: December 15, 2009
Last updated: July 25, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Pain
Weakness
Cramps
Myalgia
Side Effects of Statins
Dietary Supplement: Coenzyme Q10
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Muscle symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Continued statin use [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Muscle strength [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Disability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Adverse effects [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Coenzyme Q10 Dietary Supplement: Coenzyme Q10
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
Placebo Comparator: Placebo Other: Placebo
Placebo (three chewable tablets) 2 times daily for 4 weeks

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032993

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Catherine Buettner
Investigators
Principal Investigator: Catherine Buettner, MD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Catherine Buettner, Physician, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01032993     History of Changes
Other Study ID Numbers: K23 AR055664
Study First Received: December 15, 2009
Last Updated: July 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
CoQ10
Statins
Myalgia
Muscle Pain
Muscle Weakness

Additional relevant MeSH terms:
Asthenia
Signs and Symptoms
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on April 15, 2014