Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs

Completed · Not applicable

Conditions studied: Hypercholesterolemia, Aches, Cramps, Weakness

In brief

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.

Key facts

Study ID

NCT00797407

Run by

The Cleveland Clinic

People needed

12

Starts

2006-08-01

Expected to finish

2006-12-01

Last updated by the study team

2008-11-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Wooster Family Health Center, Cleveland Clinic — Wooster, Ohio, United States

Full record on ClinicalTrials.gov

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