Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT00127335
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00127335
Study Brief:
Protocol Section:
NCT00127335