Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications) (COSMIC)

This study has been completed.
Information provided by (Responsible Party):
David Rott, Hadassah Medical Organization Identifier:
First received: July 14, 2008
Last updated: January 24, 2013
Last verified: January 2013
The purpose of this study is to determine whether Coenzyme Q 10 supplementation will decrease the rate of Muscle Pain in patients with previous statin related Muscle Pain.

Condition Intervention
Statin Induced Myalgia
Drug: Coenzyme Q 10
Drug: Placebo control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 1. The number of patients who tolerate statin at the initial dose. 2. The number of patients remaining on statin therapy. 3. Change in myalgia score. [ Time Frame: 4, 8, and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: January 2009
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
PO Placebo QD
Drug: Placebo control
po Placebo QD
Experimental: 1
PO Coenzyme Q 10 QD
Drug: Coenzyme Q 10
PO Coenzyme Q 10 120 mg QD
Other Name: ubiquinone


Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients treated for hyperlipidemia with a HMG-CoA reductase inhibitor (i.e. pravastatin, simvastatin rosuvastatin or atorvastatin) and reporting myopathic symptoms

Exclusion Criteria:

  • Patients with other identifiable cause of myopathy. Patients with clinical evidence of hepatic, renal, or endocrine disease; coagulopathy; or other serious medical conditions will be excluded.
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Please refer to this study by its identifier: NCT00716612

Hadassah-Hebrew University Medical Center
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: David Rott, MD Hadassah-Hebrew University Hospital
  More Information

No publications provided

Responsible Party: David Rott, Consultant, Hadassah Medical Organization Identifier: NCT00716612     History of Changes
Other Study ID Numbers: Solgar-080
Study First Received: July 14, 2008
Last Updated: January 24, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Coenzyme Q 10

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Coenzyme Q10
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vitamins processed this record on November 27, 2015