Status:
COMPLETED
Red Yeast Rice and Phytosterols In Statin Intolerance
Lead Sponsor:
Chestnut Hill Health System
Conditions:
Hyperlipidemia
Eligibility:
All Genders
21+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Detailed Description
Although recent studies have shown that red yeast rice is an effective therapy in the treatment of hyperlipidemia, additional supplements may be required to lower cholesterol to levels that have been ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00897975
Start Date
July 1 2009
End Date
July 1 2011
Last Update
July 18 2011
Active Locations (2)
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1
Abington Memorial Hospital
Abington, Pennsylvania, United States
2
Chestnut Hill Hospital
Philadelphia, Pennsylvania, United States, 19118