Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
Primary Purpose
Statin-associated Myalgia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
coenzyme Q10
matching placebo
Sponsored by
About this trial
This is an interventional treatment trial for Statin-associated Myalgia focused on measuring coenzyme Q10, statin, myalgia
Eligibility Criteria
Inclusion Criteria:
- Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level
Exclusion Criteria:
- Women of childbearing potential
- Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)
- Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins
- Patients with a history of alcoholism or malnutrition
- Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days
- Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.
Sites / Locations
- The Cardiac Center of Creighton University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Secondary Outcome Measures
evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Full Information
NCT ID
NCT00590408
First Posted
December 28, 2007
Last Updated
November 27, 2009
Sponsor
Creighton University
1. Study Identification
Unique Protocol Identification Number
NCT00590408
Brief Title
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitment
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Creighton University
4. Oversight
5. Study Description
Brief Summary
Statins are medications that lower blood cholesterol by inhibiting cholesterol production in the liver. Overall, statins are well tolerated. Approximately 10% to 15% of patients report muscle aches/pain while taking statins. In a very small percentage of patients (<0.01%; less than one in 10,000 people), muscle aches/pains may be accompanied by more serious muscle damage. In these patients, statins must be discontinued. In some reports, patients taking statins have reduced blood levels of coenzyme Q10. Coenzyme Q10 is an essential protein which is present in all human cells needed for normal cell function. Coenzyme Q10 has been tested in patients with heart failure where it has been shown to be safe and effective. Many patients with heart conditions take coenzyme Q10, but the risks and benefits of supplementation with this product is unknown. Coenzyme Q10 is considered a dietary supplement and is not approved by the Food and Drug Administration (FDA) for any medical condition. Coenzyme Q10 has very few, if any, side effects. Upset stomach (gastritis), headache, body ache, and low blood pressure have been reported. The objectives of this project are to test the efficacy and safety of coenzyme Q10 in treating muscle aches/pain in patients already taking statins who develop these symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Statin-associated Myalgia
Keywords
coenzyme Q10, statin, myalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
coenzyme Q10
Intervention Description
60mg capsule twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
matching placebo
Intervention Description
matching placebo capsule twice daily for 12 weeks
Primary Outcome Measure Information:
Title
evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Time Frame
every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks
Secondary Outcome Measure Information:
Title
evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy
Time Frame
every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level
Exclusion Criteria:
Women of childbearing potential
Patients currently taking coenzyme Q10 (or have taken in the previous 30 days)
Patients receiving concomitant niacin, fibric acid derivatives, bile acid sequestrants, or other drugs that effect cholesterol levels or interact with statins
Patients with a history of alcoholism or malnutrition
Patients who have had acute coronary syndrome or muscle trauma in the prior 7 days
Patients with a history of chronic muscle/joint pain, fibromyalgia, or degenerative disk disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robyn Kondrack, PharmD
Organizational Affiliation
Creighton University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Cardiac Center of Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
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