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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Rott, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00716612
First received: July 14, 2008
Last updated: January 24, 2013
Last verified: January 2013
  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
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

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: David Rott, Consultant, Hadassah Medical Organization
ClinicalTrials.gov 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
Statin
Myalgia

Additional relevant MeSH terms:
Myalgia
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Coenzyme Q10
Ubiquinone
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 29, 2014