drugset / Trial / NCT00816829

Effect of Fenofibrate on Sleep Apnea Syndrome

NCT00816829 ↗

Phase 2 Terminated 34 enrolled Solvay Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.

Timeline

Start
2005-09
Primary completion
2008-01
Completion
2008-01

Outcome

Mixed primary results

Stopped (Enrollment): “The study was prematurely terminated because of slow recruitment”

registry MEDIAN Placebo: 30.5 (0 to 318) Number of obstructive apneas MEDIAN Fenofibrate: 15.0 (0 to 168) Number of obstructive apneas NCT00816829 ↗

registry analysis (superiority or other test); Placebo vs Fenofibrate; p = 0.048; ANCOVA NCT00816829 ↗

registry analysis (superiority or other test); Placebo vs Fenofibrate; p = 0.007; Wilcoxon (Mann-Whitney) NCT00816829 ↗

registry analysis (superiority or other test); Placebo vs Fenofibrate; p = 0.203; ANCOVA NCT00816829 ↗

registry analysis (superiority or other test); Placebo vs Fenofibrate; p = 0.533; ANCOVA NCT00816829 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Fenofibrate Small molecule 145 mg —