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

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00797407
First received: November 24, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 24, 2008
November 24, 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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
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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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00797407
06-297
No
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