Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
|ClinicalTrials.gov Identifier: NCT01032993|
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : January 23, 2017
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Weakness Cramps Myalgia or Myositis Nos HMG COA Reductase Inhibitor Adverse Reaction||Dietary Supplement: Coenzyme Q10 Other: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
U.S. FDA Resources
Active Comparator: Coenzyme Q10
600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily. Study wafers: ChewQ (Tishcon Corp, Westbury, NY) are chewable wafers each containing 100 mg of Coenzyme Q10 (ubidecarenone USP). All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Dietary Supplement: Coenzyme Q10
300 mg of CoQ10 (three 100 mg chewable tablets) 2 times daily for 4 weeks
Placebo Comparator: Placebo
Placebo was manufactured by the manufacturer of ChewQ, Tishcon Corp (Westbury, NY), included the same excipients, but no active CoQ10, and looked and tasted identical to active agent. All participants randomized continued use of simvastatin 20 mg started during the run-in phase of the study.
Placebo (three chewable tablets) 2 times daily for 4 weeks
- Percentage of Participants With Reduction in Muscle Pain Associated With Statin Use [ Time Frame: 4 weeks ]Clinically significant pain reduction was defined, a priori, as a reduction > 1.5 points on the Brief Pain Inventory-Severity Scale (BPI-SS), range: 0 to 10
- Continuation of Statin [ Time Frame: 4 weeks ]Adherence of statin use was defined a priori as participant using Simvastatin 20 mg /day at the end of 4 weeks and having used >85% of statin doses.
- Percentage of Participants With Improvement in Disability Related to Muscle Pain [ Time Frame: 4 weeks ]Disability improvement was based on patient report of improvement they felt was meaningful to them
- Percentage of Participants With Adverse Effects [ Time Frame: 4 weeks ]serious adverse effects and possible side effects were tracked through all phases of the study by participant interview and checklist at each visit, up to 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032993
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Catherine Buettner, MD, MPH||Beth Israel Deaconess Medical Center|