Phase
Condition
Elevated Triglycerides (Hypertriglyceridemia)
Dyslipidemia
Hypercholesterolemia
Treatment
N/AClinical Study ID
Ages > 21 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 feelsmay be attributable to statin therapy
Having stopped a statin drug for personal reasons and not willing to restart thismedication
Refusal to take a statin as prescribed by personal physician
CPK < 400
Not taking any cholesterol lowering medication, red yeast rice extract or aphytosterol 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
Exclusion Criteria:
A history of muscle damage (CPK > 400 IU) on statin therapy
Any active cardiac problem including chest pain, angina, shortness of breath withminimal 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 pulmonarydisease
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 macrolideantibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily
Study Design
Study Description
Connect with a study center
Abington Memorial Hospital
Abington, Pennsylvania
United StatesSite Not Available
Chestnut Hill Hospital
Philadelphia, Pennsylvania 19118
United StatesSite Not Available
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