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Is Myopathy Part of Statin Therapy (IMPOSTER-16)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127335
Recruitment Status : Terminated (Lack of funding)
First Posted : August 5, 2005
Last Update Posted : July 28, 2011
Information provided by:
Scripps Health

Tracking Information
First Submitted Date  ICMJE August 4, 2005
First Posted Date  ICMJE August 5, 2005
Last Update Posted Date July 28, 2011
Study Start Date  ICMJE August 2005
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • hip flexion [ Time Frame: 8 weeks ]
  • grip strength [ Time Frame: 8 weeks ]
  • oxygen consumption and anaerobic threshold [ Time Frame: 8 weeks ]
  • muscle pathology score [ Time Frame: at entry ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 4, 2005)
  • hip flexion
  • grip strength
  • oxygen consumption and anaerobic threshold
  • muscle pathology score
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • ability to identify blinded statin [ Time Frame: 8 weeks ]
  • other aerobic exercise indexes [ Time Frame: 8 weeks ]
  • fatty acid oxidation of myocyte cell cultures [ Time Frame: at entry ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2005)
  • ability to identify blinded statin
  • other aerobic exercise indexes
  • fatty acid oxidation of myocyte cell cultures
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Is Myopathy Part of Statin Therapy (IMPOSTER-16)
Official Title  ICMJE Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy
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 diagnostic for myopathy.
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 creatine kinase (CK) enzyme determinations have been normal will be enrolled voluntarily. All patients will have a percutaneous muscle biopsy prior to enrollment into the trial. These patients will be randomized in a blinded crossover fashion to either standardized statin therapy or placebo in eight week intervals. After eight weeks of drug or placebo the patients will be assessed for signs and symptoms of muscle weakness by:

  • Dynamometry of grip and hip strength
  • An exercise test with exhaled gas analysis
  • Blood tests for cholesterol, creatine kinase, lactate
  • Urine tests for organic acids

Following the first eight-week study and testing period, each patient will serve as their own control and they will enter a second eight-week study period. During the second phase they will take the opposite therapy, either drug or placebo, which they have not yet received. Sub-studies will include ten controls who have never previously received statins and ten subjects who have suffered statin-induced rhabdomyolysis. Subjects in these sub-studies will not be exposed to statin therapy and will only undergo limited testing.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Myopathic Conditions
Intervention  ICMJE Drug: cellulose placebo vs. atorvastatin
Other Name: atorvastatin
Study Arms  ICMJE
  • Placebo Comparator: 1
    Intervention: Drug: cellulose placebo vs. atorvastatin
  • Active Comparator: 2
    statin administration
    Intervention: Drug: cellulose placebo vs. atorvastatin
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: August 4, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00127335
Other Study ID Numbers  ICMJE M-05-001 (MER004241)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul Phillips,, MD, Scripps Health - Scripps Mercy Hospital
Study Sponsor  ICMJE Scripps Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul S Phillips, MD Scripps Health
Study Director: Harminder Sikand, PharmD Scripps Mercy
PRS Account Scripps Health
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP