Trial record 6 of 155 for:
Open Studies | "Hydroxymethylglutaryl-CoA Reductase Inhibitors"
Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design
This study is currently recruiting participants.
Verified June 2011 by Lawson Health Research Institute
Sponsor:
Lawson Health Research Institute
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01259791
First received: December 13, 2010
Last updated: June 29, 2011
Last verified: June 2011
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Purpose
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 history of statin-related myopathy.
| Condition | Intervention |
|---|---|
|
Statin Myopathy |
Drug: Individual-specific statin causing myopathy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Evaluation of Patients With Statin Myopathy Using an N of 1 Trial Design |
Resource links provided by NLM:
Further study details as provided by Lawson Health Research Institute:
Primary Outcome Measures:
- To assess the reliability and reproducibility of subjective symptoms of myalgias to active statin therapy. [ Time Frame: Duration of study September 2010 to August 2013 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To delineate the relation of objective changes in non-invasive neuromuscular testing to subjective symptoms during the first exposure to active or placebo therapy, in subset of 5 patients with prior history of statin myopathy. [ Time Frame: September 2010 to August 2013 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Statin, myalgias
Statin causing myopathic symptoms in patient (can be any of the following statins: rosuvastatin, atorvastatin, simvastatin, fluvastatin, pravastatin in any of the does causing myalgias in patient.
|
Drug: Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo
|
|
Placebo Comparator: statin
Identical placebo to patient-specific statin
|
Drug: Individual-specific statin causing myopathy
Individual-specific statin causing myopathy vs. placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Exclusion Criteria:
- same as above but also:
- angina III of IV
- decompensated heart failure
- history of orthopedic problems
- have any skin ulcers or other non-healed skin areas or infections in the arm or leg
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259791
Contacts
| Contact: Tisha Joy, MD, FRCPC, Cert Endo | 519-646-6296 | tisha.joy@sjhc.london.on.ca |
| Contact: Lynda Bere, RN | 519-646-6000 ext 65996 |
Locations
| Canada, Ontario | |
| St. Joseph's Health Care | Recruiting |
| London, Ontario, Canada, N6A 4V2 | |
| Contact: Tisha Joy, MD, FRCPC 519-646-6296 tisha.joy@sjhc.london.on.ca | |
| Contact: Lynda Bere, RN 519-646-6000 ext 65996 | |
| Principal Investigator: Tisha Joy, MD, FRCPC | |
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
| Principal Investigator: | Tisha Joy, MD, FRCPC, Cert Endo | St. Joseph's Health Care, UWO |
More Information
No publications provided
| Responsible Party: | Dr. Tisha Joy/ Principal Investigator, St. Joseph's Health Care, Department of Medicine, UWO |
| ClinicalTrials.gov Identifier: | NCT01259791 History of Changes |
| Other Study ID Numbers: | R-10-450, 17352 |
| Study First Received: | December 13, 2010 |
| Last Updated: | June 29, 2011 |
| Health Authority: | Canada: Ethics Review Committee |
Additional relevant MeSH terms:
|
Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013