drugset / Trial / NCT02455336

Fenofibrate Treatment in SCI

NCT02455336

Phase 2/3 Completed 23 enrolled VA Office of Research and Development
RandomizedParallel-groupOpen-labelTreatment

Summary

Cardiovascular disease-related morbidity in persons with spinal cord injury (SCI) occurs earlier in life, at a greater prevalence than that of the general population, and is the primary cause of death after the first year of injury. During the chronic phase of SCI, a characteristic dyslipidemia emerges, which is characterized by low serum high density lipoprotein cholesterol (HDL-C) concentrations, with values often qualifying to be an independent risk factor for coronary artery disease, and elevations in serum triglycerides (TG). Serum low density lipoprotein cholesterol concentrations in those with SCI are usually similar to those of the general population. The current proposal in persons with SCI aims to determine the safety and efficacy of short-term fenofibrate treatment, an anti-lipid medication whose primary action lowers serum TG and raises serum HDL-C levels.

Timeline

Start
2015-05-18
Primary completion
2018-08-01
Completion
2018-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 145 mg