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

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ClinicalTrials.gov Identifier: NCT00716612
Recruitment Status : Completed
First Posted : July 16, 2008
Last Update Posted : January 25, 2013
Information provided by (Responsible Party):
David Rott, Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment
Statin Induced Myalgia Drug: Coenzyme Q 10 Drug: Placebo control

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Coenzyme Q 10 Supplementation on Myalgia Induced by HMG-CoA Reductase Inhibitors
Study Start Date : January 2009
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT00716612

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

Responsible Party: David Rott, Consultant, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00716612     History of Changes
Other Study ID Numbers: Solgar-080
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

Keywords provided by David Rott, Hadassah Medical Organization:
Coenzyme Q 10

Additional relevant MeSH terms:
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Coenzyme Q10
Growth Substances
Physiological Effects of Drugs