Effect of Fenofibrate on Sleep Apnea Syndrome

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Treatments: Fenofibrate

Criteria

Inclusion Criteria:

• Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea

• Overweight or obese, with BMI >= 25 kg/m² and < 40 kg/m².

• Known moderate hypertriglyceridemia, with fasting Triglycerides level >= 2.0 and < 6.0 mmol/L within 3 months before the inclusion.

Exclusion Criteria:

• indication for immediate CPAP

• other known endocrine disease, except treated and adequately controlled hypothyroidism

• renal failure or plasma creatinine level >130 µmol/L

• current chronic liver disease or ALanine Amino Transferase (ALT)> 2 times the upper normal limit (UNL)

• symptomatic gallbladder disease

• known muscular disease or creatine phosphokinase (CK) > 3 times UNL.