search
Back to results

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
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Statin-associated Myalgia focused on measuring coenzyme Q10, statin, myalgia

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 28, 2007
Last Updated
November 27, 2009
Sponsor
Creighton University
search

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

We'll reach out to this number within 24 hrs