Is Myopathy Part of Statin Therapy (IMPOSTER-16)

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by:
Scripps Health
ClinicalTrials.gov Identifier:
NCT00127335
First received: August 4, 2005
Last updated: July 26, 2011
Last verified: July 2011

August 4, 2005
July 26, 2011
August 2005
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • hip flexion
  • grip strength
  • oxygen consumption and anaerobic threshold
  • muscle pathology score
Complete list of historical versions of study NCT00127335 on ClinicalTrials.gov Archive Site
  • 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 ]
  • ability to identify blinded statin
  • other aerobic exercise indexes
  • fatty acid oxidation of myocyte cell cultures
Not Provided
Not Provided
 
Is Myopathy Part of Statin Therapy (IMPOSTER-16)
Double Blind, Prospective Randomized, Crossover Study of Patients With Muscle Complaints on Statin Therapy

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Myopathic Conditions
Drug: cellulose placebo vs. atorvastatin
drug
Other Name: atorvastatin
  • Placebo Comparator: 1
    Intervention: Drug: cellulose placebo vs. atorvastatin
  • Active Comparator: 2
    statin administration
    Intervention: Drug: cellulose placebo vs. atorvastatin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00127335
M-05-001 (MER004241)
No
Paul Phillips,, MD, Scripps Health - Scripps Mercy Hospital
Scripps Health
Not Provided
Principal Investigator: Paul S Phillips, MD Scripps Health
Study Director: Harminder Sikand, PharmD Scripps Mercy
Scripps Health
July 2011

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