Efficacy and Safety of Coenzyme Q10 in the Treatment of Statin-Associated Myalgia

NCT00590408 | Terminated Phase 4

• 1 other identifier: 05-13642
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Statin-associated Myalgia

Keywords

coenzyme Q10; statin; myalgia

Outcome Measures

Primary Outcomes (1)

• evaluate the efficacy coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy

  every 3-5 days during the first week 2 weeks, then at 4 weeks and 12 weeks

Secondary Outcomes (1)

• evaluate the safety of coenzyme Q10 in the treatment of myalgia in patients receiving statin therapy

  every 3-5 days during the first week 2 weeks, then at 4 week and 12 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Dietary Supplement: coenzyme Q10

2

PLACEBO COMPARATOR

Dietary Supplement: matching placebo

Interventions

coenzyme Q10 DIETARY_SUPPLEMENT

60mg capsule twice daily for 12 weeks

1

matching placebo DIETARY_SUPPLEMENT

matching placebo capsule twice daily for 12 weeks

2

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are taking statins and develop unexplained, persistent myalgia with a normal plasma creatinine kinase level

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creighton University: lead

Study Sites (1)

The Cardiac Center of Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Myalgia

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robyn Kondrack, PharmD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 10, 2008
• Study Start: March 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (1)