Does Coenzyme Q 10 Supplementation Reduce Muscle Pain Caused by Statins? (Cholesterol Lowering Medications) (COSMIC)
This study has been completed.
Sponsor:
Hadassah Medical Organization
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
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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:
MedlinePlus related topics:
Statins
Drug Information available for:
Ubidecarenone
U.S. FDA Resources
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
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:
|
Coenzyme Q10 Ubiquinone Hydroxymethylglutaryl-CoA Reductase Inhibitors Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Vitamins |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013