Red Yeast Rice and Phytosterols In Statin Intolerance

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins. The addition of an over-the-counter phytosterol to red yeast rice may offer additional lipid lowering benefits when compared to red yeast rice alone. These supplements will be given to all participants. Up to one-half will enroll in a lifestyle intervention program called Change of Heart and will be compared to patients who do not participate in the program. The study will last one year.

Key facts

Study ID

NCT00897975

Run by

Chestnut Hill Health System

People needed

200

Starts

2009-07-01

Expected to finish

2011-07-01

Last updated by the study team

2011-07-18

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Men and women age > 21
• LDL > 100 and physician suggestion to take statin
• Subject complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy
• Having stopped a statin drug for personal reasons and not willing to restart this medication
• Refusal to take a statin as prescribed by personal physician
• CPK < 400
• Not taking any cholesterol lowering medication, red yeast rice extract or a phytosterol product for at least 1 month prior to initiation of trial
• Ability to exercise without physical restrictions
• Ability to attend 12 week consecutive Change of Heart lifestyle education sessions
• Liver function studies normal at baseline
• Subject willing to remain off the dietary supplement CoQ10 for duration of trial
• TSH must be normal

You may not qualify if…

• A history of muscle damage (CPK > 400 IU) on statin therapy
• Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year
• Known intolerance to one of the study drugs
• Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease
• Uncontrolled hypertension (defined as SBP > 180 mmHg or DBP > 100 mmHg
• Heart attack, bypass surgery, or angioplasty/stent within 1 year of study
• Triglyceride level more than 400 mg/dl
• Underlying musculoskeletal disorder preventing muscle testing
• Taking other medicines including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily

Where it is running

• Abington Memorial Hospital — Abington, Pennsylvania, United States
• Chestnut Hill Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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