Expired Study
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Wooster, Ohio 44691


Purpose:

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 patients who have had this side effect from 3 different statin drugs.


Study summary:

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 is a test of oral creatine supplementation in statin intolerant subjects as a method of preventing the onset of this side effect as well as resolving these symptoms when present during statin therapy.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT00797407


Primary Contact:

Principal Investigator
David A Shewmon, MD
The Cleveland Clinic


Backup Contact:

N/A


Location Contact:

Wooster, Ohio 44691
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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