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Quality of Life in Patients With Statin-Associated Myopathy

NCT00850460 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-11-07

Study results available
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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.

Conditions

  • Statin Adverse Reaction

Interventions

DRUG

Statins

Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth.

DRUG

Placebo

Placebo pills will consist of lactose and will be given one capsule once daily

Sponsors & Collaborators

  • Cornell University

    collaborator OTHER

  • Adelphi University

    collaborator OTHER

  • Rockefeller University

    lead OTHER

Principal Investigators

  • Patricia D Maningat, MD · Rockefeller University

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00850460 on ClinicalTrials.gov