Is Myopathy Part of Statin Therapy (IMPOSTER-16) (NCT00127335) | Clinical Trial Compass
WithdrawnPhase 4
Is Myopathy Part of Statin Therapy (IMPOSTER-16)
Stopped: Lack of funding
United States0Started 2005-08
Plain-language summary
There is a significant proportion of patients complaining of muscle symptoms while on statin therapy who have a measurable difference in muscle strength or endurance and whose muscle biopsies are diagnostic for myopathy.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary doctor's permission
* Patient understands nature of study and has signed consent
* Patient is \>21 years of age
* Patient willing to stop statin for up to 12 weeks and remain off CoQ10 for study duration
* Patient able to perform the strength and functional tests required
* Patient complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy
* CK \< 350 IU
* Thyroid stimulating hormone (TSH) must be normal
* Fasting respiratory exchange ratio (RER) \> 0.80 off statin for at least 4 weeks
Exclusion Criteria:
* Severe underlying illness including: Cr \> 3.0, liver failure, unstable angina, symptomatic valvular heart disease, congestive heart failure, or prior cerebrovascular accident (CVA) preventing exercise testing.
* History of muscle damage (CK \> 350 IU) on statins
* Underlying musculoskeletal disorder preventing muscle testing
* History of severe depression
* Taking doses of other medicines with statin sufficient to cause myopathy including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or \> 16 oz. of grapefruit juice daily.
* Diabetes requiring other than diet therapy
* Use of thiazolidinediones (TZD's), protease inhibitors or other drugs known to influence RER or fatty acid oxidation.
* Abnormal thyroid status
* Inability to maintain constant exercise, dietary, and drug regimen during the 16 weeks required by the study protocol.