Status:
COMPLETED
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Chestnut Hill Health System
Conditions:
Hypercholesterolemia
Statin-Associated Myopathy
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate stati...
Detailed Description
20 million Americans are actively treated with statins at an annual cost of 16 billion dollars. Statins are effective therapeutic agents for reducing LDL cholesterol and have documented effectiveness....
Eligibility Criteria
Inclusion
- Subject reports stopping at least one statin drug due to complaints of muscle pain or weakness which his/her physician thinks was attributable to the drug.
- Subject has never taken pravastatin.
- Subject willing to remain off the dietary supplements CoQ10, L-carnitine, fish oil, policosanol, and guggulipid, garlic, and phytosterols in margarines (e.g. Benecol, Promise activ), milk or cereal products, for one month prior to the trial and for the duration of the trial.
Exclusion
- A history of muscle damage (CK\>1000 IU) on statin therapy.
- A history of generalized chronic pain such as fibromyalgia, or generalized arthritis.
- Any active cardiac problem including chest pain, angina, heart attack, bypass surgery, angioplasty/stent or unstable angina/acute coronary syndrome within the past 6 months.
- Taking other lipid lowering drugs including: ezetimibe, gemfibrozil, niacin, fibrates or bile acid sequestrants.
- Triglyceride level more than 400 mg/dl.
- Taking weight loss medication including orlistat, sibutramine, diethylpropion, phendimetrazine, phentermine.
- Taking pain medication or systemic steroids on a chronic basis.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00639223
Start Date
January 1 2008
End Date
October 1 2008
Last Update
January 18 2010
Active Locations (1)
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1
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118