drugset / Trial / NCT00850460

Quality of Life in Patients With Statin-Associated Myopathy

NCT00850460

RandomizedParallel-groupTriple-blind

Summary

The proposed study will focus on possible effects of statins on muscle strength and why they become tired more easily, quality of life, and measurements to understand why muscles are not able to fully utilize fats. The investigators are specifically interested in statin users and the impact of muscle symptoms on daily activities and quality of life. This study hypothesize that patients with likely statin-associated myopathy have a metabolic dysregulation in fuel utilization such that compared to patients continuing statins, those on placebo will show: 1. improved Individualized Neuromuscular Quality of Life (INQoL) and Short Form-36 (SF-36) scores (primary end point) 2. alleviation of muscle symptoms, 3. increased utilization of fatty acids as a fuel source reflected by the metabolic test results 4. decreased intramyocellular lipid (IMCL) 5. improved insulin sensitivity.

Timeline

Start
2009-02
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Atorvastatin Small molecule Oral
Comparator Pravastatin Small molecule Oral
Comparator Rosuvastatin Small molecule Oral
Comparator Simvastatin Small molecule Oral

Indications