Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Pain Clinical Trial

Official title:

Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01032993
• Other study ID #: K23AR055664
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: December 15, 2009
• Last updated: December 3, 2015
• Start date: December 2009
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.

Description:

This study will recruit individuals who have had muscle symptoms while using a statin. During the first part of the study, volunteers will be given a statin medication to see if their muscle symptoms return. Those who experience muscle symptoms on this statin rechallenge will be invited to continue in the second part of the trial, in which participants will be randomly assigned to receive either CoQ10 or a placebo (sugar pill) to take with statin medication. We hypothesize that those who receive CoQ10 will experience an improvement in their muscle symptoms compared to those who receive placebo, and, secondarily, that those who receive CoQ10 will be more likely to continue taking the statin medication.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients with a history of muscle symptoms (such as aches, pains, cramps and/or weakness) while taking a statin drug that persisted for at least 2 weeks on a statin

Exclusion Criteria:

• Plasma creatine kinase levels > 3 times the upper normal limit

• Liver enzymes, alanine transferase (ALT) or aspartate transferase (AST) > 2 times the upper normal limit

• Pregnancy or breastfeeding (a contraindication for statin use)

• Severe renal impairment, defined as glomerular filtration rate (GFR) < 30 ml/min/1.73 m2

• Bleeding disorder, current use of warfarin, an international normalized ratio (INR) greater than 1.5, or a platelet count less than 100,000 mm3

• Contraindication to strength testing, including myocardial infarction, unstable angina, or revascularization procedure within the past six weeks, a history of brain aneurysm or stroke

• Chest or abdominal surgery within the past six weeks

• Severe persistent pain related to other causes

• Unable to complete self-administered questionnaires, or unable to read or converse in English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cramps
• Myalgia
• Pain
• Side Effects of Statins
• Weakness

Intervention

Dietary Supplement:
• Coenzyme Q10
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks

Other:
• Placebo
Placebo (three chewable tablets) 2 times daily for 4 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Catherine Buettner	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle symptoms		4 weeks	No
Secondary	Continued statin use		4 weeks	No
Secondary	Muscle strength		4 weeks	No
Secondary	Disability		4 weeks	No
Secondary	Adverse effects		4 weeks	Yes