- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00590408
Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia
November 27, 2009 updated by: Creighton University
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nebraska
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Omaha, Nebraska, United States, 68131
- The Cardiac Center of Creighton University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
|
matching placebo capsule twice daily for 12 weeks
|
Active Comparator: 1
|
60mg capsule twice daily for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robyn Kondrack, PharmD, Creighton University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
December 28, 2007
First Submitted That Met QC Criteria
January 9, 2008
First Posted (Estimate)
January 10, 2008
Study Record Updates
Last Update Posted (Estimate)
December 1, 2009
Last Update Submitted That Met QC Criteria
November 27, 2009
Last Verified
November 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-13642
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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