Status:
COMPLETED
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Statin Myopathy
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
This study consists of a series of prospective, randomized placebo-controlled n of 1 trials to objectively evaluate the reproducibility of subjective and objective symptoms among patients with a histo...
Eligibility Criteria
Inclusion
- history of muscle symptoms occuring within 3 weeks of starting a statin
- need for statin therapy to achieve LDL target according to the 2009 Canadian Lipid Guidelines
- willingness to re-try statin therapy
Exclusion
- currently tolerant of statin therapy
- metabolic or inflammatory myopathy
- known neuropathy
- CK elevation \>3 times upper limit of normal (ULN) previously on a statin or history of rhabdomyolysis
- pregnant, breastfeeding, or wanting to become pregnant in the near future
- participation in another clinical trial
- other medical condition associated with decreased life span
- inability to adhere to stringent regimen
- unwilling to stop consumption of grapefruit juice
- Subset of 5 patients also completing neuromuscular testing:
- Inclusion Criteria:
- \- same as above
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01259791
Start Date
September 1 2010
End Date
August 1 2013
Last Update
March 15 2017
Active Locations (1)
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1
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2