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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716612
First Posted: July 16, 2008
Last Update Posted: January 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
David Rott, Hadassah Medical Organization
  Purpose
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
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

Resource links provided by NLM:


Further study details as provided by David Rott, 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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): NCT00716612


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

Responsible Party: David Rott, Consultant, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00716612     History of Changes
Other Study ID Numbers: Solgar-080
First Submitted: July 14, 2008
First Posted: July 16, 2008
Last Update Posted: January 25, 2013
Last Verified: January 2013

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

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