Effect of Fenofibrate on Sleep Apnea Syndrome

Phase 2

Terminated

• Conditions: Dyslipidemia; Sleep Apnea Syndrome; Overweight; Obesity
• Interventions: Drug: Placebo; Drug: Fenofibrate

• Registration Number: NCT00816829
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2009-01-02
• Study First Submitted QC: 2009-01-02
• Study First Posted: 2009-01-05
• Results First Submitted: 2009-01-08
• Results First Submitted QC: 2009-05-25
• Status Verified: 2009-07
• Results First Posted: 2009-07-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Fenofibrate-matching placebo tablet
2	Fenofibrate	145 mg NanoCrystal fenofibrate tablet

Primary Outcome Measures

Name	Time	Method
Obstructive Apneas	at one month of treatment	Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).
Desaturations	at one month of treatment	Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.
Sleep Time With Oxygen Saturation Below 90%	at one month of treatment	Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.
Apneas	at one month of treatment	Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment
Hypopneas	at one month of treatment	Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.
Index Apnea/Hypopnea	at one month of treatment	Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Mixed Apneas	at one month of treatment	Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.
Central Apneas	at one month of treatment	Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.
Index of Apneas	at one month of treatment	Average number of apneas per hour of sleep during one night after one month of treatment.
Index of Hypopneas	at one month of treatment	Average number of hypopneas per hour of sleep during one night after one month of treatment.

Trial Locations

Locations (1)

Site 1; 🇫🇷 Paris, France