Status:
WITHDRAWN
Is Myopathy Part of Statin Therapy (IMPOSTER-16)
Lead Sponsor:
Scripps Health
Conditions:
Myopathic Conditions
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief 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 diag...
Detailed Description
This is a double-blinded, randomized, placebo-controlled, crossover trial. Sixty patients who are identified by their physician as having muscle pain or weakness while on statin therapy and in whom cr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00127335
Start Date
August 1 2005
End Date
May 1 2008
Last Update
November 23 2022
Active Locations (1)
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1
Scripps Mercy Hospital
San Diego, California, United States, 92103