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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00797407
First Posted: November 25, 2008
Last Update Posted: November 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Cleveland Clinic
November 24, 2008
November 25, 2008
November 25, 2008
August 2006
December 2006   (Final data collection date for primary outcome measure)
Combined visual analog pain scales (0-10) for aching, cramping and weakness [ Time Frame: 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 ]
Same as current
No Changes Posted
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Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs
Creatine Supplementation for the Prevention of Statin Myalgia
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Hypercholesterolemia
  • Aches
  • Cramps
  • Weakness
Dietary Supplement: Creatine
Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day
Other Name: creatine monohydrate
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
December 2006
December 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00797407
06-297
No
Not Provided
Not Provided
David A. Shewmon MD / Endocrinologist, Cleveland Clinic Foundation
The Cleveland Clinic
Not Provided
Principal Investigator: David A Shewmon, MD The Cleveland Clinic
The Cleveland Clinic
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP