CoEnzyme Q10 in Statin Myopathy
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|ClinicalTrials.gov Identifier: NCT01140308|
Recruitment Status : Unknown
Verified September 2012 by Hartford Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 9, 2010
Last Update Posted : September 7, 2012
Statins (such as simvastatin or Zocor) are the most effective and widely prescribed medications to lower cholesterol levels and reduce the frequency of heart attacks, cardiac deaths and strokes. Unfortunately, statins can cause muscle discomfort or pain called "myalgia" in patients treated with these drugs. These symptoms often cause patients who need these medications to stop taking the drug. The cause of statin muscle pain is not known, but it is thought that a reduction of a vitamin-like substance called Coenzyme Q10 (CoQ10) during statin treatment may play a role. CoQ10 is a vitamin like substance and is not a drug approved and regulated by the Food and Drug Administration (FDA). This study will look at the effects of CoQ10 supplements on individuals who develop muscle symptoms while on simvastatin.
The investigators hope to test the hypothesis that CoQ10 supplementation compared to placebo in patients with documented statin myalgia reduces the intensity of pain during statin treatment.
|Condition or disease||Intervention/treatment||Phase|
|Statin Myopathy||Drug: CoEnzyme Q10 Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||135 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||CoEnzyme Q10 in Statin Myopathy|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2013|
Placebo Comparator: Sugar Pill
Simvastatin 20mg + Placebo
Randomization to Treatment: Simvastatin 20mg + Placebo 600mg Load Subjects for 2 weeks on Treatment Eight weeks of treatment
Other Name: Sugar pill
Active Comparator: Co Q10
Simvastatin 20mg + CoQ10
Drug: CoEnzyme Q10
Randomization to Treatment: Simvastatin 20mg + 600 mg CoQ10 (pill) Load Subjects for 2 weeks on Treatment (CoQ10) Eight weeks of Treatment
- To test the hypothesis that CoQ10 supplementation compared to placebo in patients with documented statin myalgia reduces the intensity of pain during statin treatment. [ Time Frame: We selected 8 weeks of therapy . ]Increasing pain tolerability is a key clinical measure. We selected 8 weeks of therapy for the simvastatin vs placebo and CoQ10 vs placebo sections of the study because in the largest clinical study, the median time toonset of mylagia in statin naïve subjects was 1 month (4) and statin rechallenge typically reproduces symptoms more rapidly(3). Consequently, most subjects with true statin myalgia will have clearly developed symptoms at or before 8 weeks, the point at which study procedures are completed, allowing us to accurately assess the impact of CoQ10 on muscle pain intensity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01140308
|United States, Connecticut|
|Hartford, Connecticut, United States, 06102|
|Principal Investigator:||Paul D Thompson, MD||Hartford Hospital|