drugset / Trial / NCT04507373

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events

NCT04507373

Phase 4 Terminated 3 enrolled University of Texas Southwestern Medical Center
RandomizedSingle-groupTriple-blindBasic science

Summary

Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g. pain, aches, weakness, cramps, or stiffness) (1, 2). The pathophysiology of these statin-associated muscle symptoms (SAMS) has remained elusive. Consequently, no objective diagnostic method exists, causing confusion for patient and providers since muscle symptoms can often be multifactorial.

Timeline

Start
2018-08-17
Primary completion
2021-12-20
Completion
2021-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Simvastatin Small molecule 40 mg Oral

Indications