Benefit of CoQ-10 in Patients on Statins

Completed · Not applicable · Has a placebo group

Conditions studied: Pain, Soreness, Weakness, Fatigue

In brief

This study will investigate whether a supplement called co-enzyme Q10 can help ease or eliminate some of the side effects that result from taking statin medications. These side effects include muscle pain, fatigue or muscle cramping.

Key facts

Study ID

NCT00997269

Run by

Stony Brook University

People needed

37

Starts

2009-09-01

Expected to finish

2014-07-01

Last updated by the study team

2016-05-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult men and women 21 years and older taking statin medications for hyperlipidemia under the current National Cholesterol Education Program guidelines (NCEP III) and complaining of myopathic symptoms.

You may not qualify if…

• diagnosis of cancer;
• acute illness of any sort;
• hemoglobin less than 12,
• creatinine greater than 1.5 mg/dl;
• liver dysfunction as evidenced by elevations in transaminases 3-fold higher than upper limit of normal;
• use of certain medications or nutritional supplements within the past month;
• untreated hypertension (diastolic BP> 100 mm HG);
• diagnosis of diabetes mellitus (fasting blood glucose > 126 mg/dl);
• untreated hypothyroidism;
• overt congestive heart failure (by physical exam);
• active inflammatory diseases such as rheumatoid arthritis, lupus, etc.,
• bleeding disorders;
• history of adverse reactions besides myopathy associated with the use of statins;
• any previous adverse reaction to coQ10 or to multivitamin supplements containing coQ10;
• plasma CPK levels > 3 times the upper normal limit; OR
• congenital myopathies and/or neuromuscular degenerative diseases.

Where it is running

• Stony Brook University GCRC — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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