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Sponsored by: |
The Cleveland Clinic |
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Information provided by: | The Cleveland Clinic |
ClinicalTrials.gov Identifier: | NCT00797407 |
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.
Condition | Intervention |
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Hypercholesterolemia Aches Cramps Weakness |
Dietary Supplement: Creatine |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Creatine Supplementation for the Prevention of Statin Myalgia |
Enrollment: | 12 |
Study Start Date: | August 2006 |
Study Completion Date: | December 2006 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Wooster Family Health Center, Cleveland Clinic | |
Wooster, Ohio, United States, 44691 |
Principal Investigator: | David A Shewmon, MD | The Cleveland Clinic |
Responsible Party: | Cleveland Clinic Foundation ( David A. Shewmon MD / Endocrinologist ) |
Study ID Numbers: | 06-297 |
Study First Received: | November 24, 2008 |
Last Updated: | November 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00797407 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Creatine Adverse Effects Muscle Toxicity |
Antimetabolites Hyperlipidemias Metabolic Diseases Asthenia Antilipemic Agents Pain Anticholesteremic Agents |
Muscle Cramp Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypercholesterolemia Metabolic Disorder Dyslipidemias Lipid Metabolism Disorders |
Antimetabolites Hyperlipidemias Metabolic Diseases Molecular Mechanisms of Pharmacological Action Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Therapeutic Uses Hypercholesterolemia Dyslipidemias Lipid Metabolism Disorders |