Quality of Life in Patients With Statin-Associated Myopathy

Statin-Associated Myopathy Clinical Trial

Official title: Quality of Life and Metabolic Alterations in Patients With Statin-Associated Myopathy

Status Terminated

Clinical Trial 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 INQoL and 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 IMCL

5. improved insulin sensitivity.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Muscular Diseases
• Statin-Associated Myopathy

• NCT number: NCT00850460
• Study type: Interventional
• Source: Rockefeller University
• Status: Terminated
• Phase: Phase 4
• Start date: February 2009
• Completion date: February 2013