Status:
TERMINATED
Effect of Fenofibrate on Sleep Apnea Syndrome
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Dyslipidemia
Sleep Apnea Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00816829
Start Date
September 1 2005
End Date
January 1 2008
Last Update
July 22 2009
Active Locations (1)
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1
Site 1
Paris, France