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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia Aches Cramps Weakness

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Hydroxymethylglutaryl-CoA Reductase Inhibitors Creatine Adverse Effects Muscle Toxicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Creatine

Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

creatine monohydrate

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cleveland Clinic Foundation

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David A Shewmon, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Wooster Family Health Center, Cleveland Clinic

Wooster, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-297

Identifier Type: -

Identifier Source: org_study_id