Completed
Creatine Supplementation for the Prevention of Statin Myalgia
What is being tested
Data Collection
Who is being recruted
Asthenia+13
+ Hypercholesterolemia
+ Hyperlipidemias
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Supportive Care Study
Interventional
Study Start: August 2006
Summary
Principal SponsorThe Cleveland Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2006
Actual date on which the first participant was enrolled.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.
Official TitleCreatine Supplementation for the Prevention of Statin Myalgia
Principal SponsorThe Cleveland Clinic
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AstheniaHypercholesterolemiaHyperlipidemiasMetabolic DiseasesMuscle CrampMuscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsNutritional and Metabolic DiseasesPainSigns and SymptomsPathological Conditions, Signs and SymptomsNeuromuscular ManifestationsDyslipidemiasLipid Metabolism Disorders
Criteria
2 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
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.
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Wooster Family Health Center, Cleveland Clinic
Wooster, United StatesOpen Wooster Family Health Center, Cleveland Clinic in Google MapsCompletedOne Study Center