Hypercholesterolemia Clinical Trial
Official title:
Creatine Supplementation for the Prevention of Statin Myalgia
Verified date | November 2008 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Wooster Family Health Center, Cleveland Clinic | Wooster | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Combined visual analog pain scales (0-10) for aching, cramping and weakness | baseline, after 5 days of creatine loading, after 6 weeks of creatine+statin, after up to 6 weeks on statin without creatine, after 4 days of rechallenge with creatine while still on statin | No |
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