CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 8 enrolled
Drug / intervention
Simvastatindrug
Likely dose
Simvastatin 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04575090
NCT04575090N/ACompleted

7 Tesla MRI Study in Patients With Statin Related Muscle Complaints

University of Texas Southwestern Medical Center·interventional·Posted Oct 5, 2020·Updated Oct 31, 2022

In Brief

A clinical study evaluating Simvastatin for Statin-related Muscle Pain and 4 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Roughly 5-10% of statin-treated patients report muscle pain, aches, weakness, cramps, stiffness, or "heaviness" - typically occurring symmetrically in the legs. For healthcare providers, the major diagnostic challenge is to unambiguously link these symptoms to statin use, especially since some patients can have normal serum creatine kinase (CK) levels despite demonstrable weakness and muscle biopsy proven statin-induced myopathy . No well accepted, standardized, or Food and Drug Administration (FDA)-endorsed diagnostic method exists for statin-induced muscle injury. This lack of an objective diagnostic methodology blocks vertical advancement of the field. The successful completion of this project will develop in vivo techniques that will provide insight into how statins affect muscle metabolism and help establish a methodology to objectively diagnose muscle injury due to statins. The development of an MRS technique will allow for in-vivo analyses and the data accumulated here will serve as preliminary data for futher extramural funding of studies with much larger sample sizes. Ultimately, this focus of research will lead to improved diagnosis and treatment of patients with statin-related muscle complaints, which is central to obtaining the cardiovascular risk reduction from lipid-lowering drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 5, 2020
Enrollment StartMar 5, 2016
Primary CompletionFeb 20, 2017
Study CompletionJun 23, 2021
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.7 years ago

Interventions

Simvastatindrug

Simvastatin 40 mg daily.