Status:
COMPLETED
Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs
Lead Sponsor:
The Cleveland Clinic
Conditions:
Hypercholesterolemia
Aches
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine of creatine will prevent or treat the muscle toxicity side effect of statin drug therapy, whose symptoms are aching, cramping, and weakness. This is tested in...
Detailed Description
Muscle toxicity is the most common limiting side effect of statin therapy. Biochemical studies have suggested the presence of intramuscular creatine deficiency in patients with muscle toxicity. This i...
Eligibility Criteria
Inclusion
- hypercholesterolemia in need of aggressive treatment, defined as a high risk of a vascular event, thus subjects with diabetes, pre-diabetes, or known vascular disease
- intolerance (i.e. muscle toxicity symptoms) of at least 3 statin drugs, each confirmed on rechallenge
Exclusion
- history of elevated CPK or rhabdomyolysis while taking a statin,
- CPK levels elevated above the normal range at baseline,
- pregnancy.
- renal insufficiency, defined as a serum creatinine ≥ 2.0 mg/dl.
- history of congestive heart failure.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00797407
Start Date
August 1 2006
End Date
December 1 2006
Last Update
November 25 2008
Active Locations (1)
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1
Wooster Family Health Center, Cleveland Clinic
Wooster, Ohio, United States, 44691