HypercholesterolemiaNCT00797407
Effectiveness of Creatine in Preventing Muscle Aching From Cholesterol-Lowering Statin Drugs
A study testing Creatine in people with Hypercholesterolemia and Aches, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Aches, Cramps
- What is being tested?
- Creatine
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wooster Family Health Center, Cleveland Clinic
Wooster, Ohio, 44691
About this study
Official title: 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.
Read the detailed description
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
- Hypercholesterolemia, Aches, Cramps, Weakness
- Being tested
- Creatine
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, Creatine, Adverse Effects, Muscle Toxicity
- Medical subject headings
- Hypercholesterolemia, Pain, Muscle Cramp, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreatineDietary supplement
Also called creatine monohydrate
Creatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined visual analog pain scales (0-10) for aching, cramping and weakness
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startAug 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Investigators
- David A Shewmon, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797407
- Sponsor's protocol ID
- 06-297
- Status last verified
- Nov 2008
- First submitted
- 24 Nov 2008
- Last updated
- 25 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Supplementation for the Prevention of Statin Myalgia
- ClinicalTrials.gov ID
- NCT00797407
- Acronym / sponsor ID
- 06-297
- Conditions
- Hypercholesterolemia, Aches, Cramps, Weakness
- Keywords
- Hydroxymethylglutaryl-CoA Reductase Inhibitors, Creatine, Adverse Effects, Muscle Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreatineAlso: creatine monohydrateCreatine 5 gm orally twice a day for 5 days, followed by 5 gm once a day | Dietary supplement | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Shewmon, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine in people with Hypercholesterolemia and Aches, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2008.