Effect of Fenofibrate on Sleep Apnea Syndrome

A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome

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

Study Overview

• Status: Terminated
• Conditions: Obesity; Overweight; Dyslipidemia; Sleep Apnea Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Fenofibrate

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; Fenofibrate-matching placebo tablet	Drug: Placebo; Fenofibrate-matching placebo tablet
Experimental: 2; 145 mg NanoCrystal fenofibrate tablet	Drug: Fenofibrate; 145 mg NanoCrystal tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obstructive Apneas	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).	at one month of treatment
Desaturations	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.	at one month of treatment
Sleep Time With Oxygen Saturation Below 90%	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.	at one month of treatment
Apneas	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	at one month of treatment
Hypopneas	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.	at one month of treatment
Index Apnea/Hypopnea	Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.	at one month of treatment
Mixed Apneas	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.	at one month of treatment
Central Apneas	Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.	at one month of treatment
Index of Apneas	Average number of apneas per hour of sleep during one night after one month of treatment.	at one month of treatment
Index of Hypopneas	Average number of hypopneas per hour of sleep during one night after one month of treatment.	at one month of treatment

Collaborators and Investigators

• Sponsor: Solvay Pharmaceuticals

Publications and helpful links

General Publications

• Bruckert E, Duchene E, Bonnefont-Rousselot D, Hansel B, Ansquer JC, Dubois A, Gaymard B. Proof of concept study: does fenofibrate have a role in sleep apnoea syndrome? Curr Med Res Opin. 2010 May;26(5):1185-92. doi: 10.1185/03007991003693581.

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 2, 2009
• First Submitted That Met QC Criteria: January 2, 2009
• First Posted (Estimate): January 5, 2009

Study Record Updates

• Last Update Posted (Estimate): July 22, 2009
• Last Update Submitted That Met QC Criteria: July 17, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: Dyslipidemia; Obese; Sleep Apnea Syndromes; Fenofibrate; Overweight or obese patients
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Body Weight; Signs and Symptoms, Respiratory; Lipid Metabolism Disorders; Sleep Apnea Syndromes; Syndrome; Apnea; Dyslipidemias; Overweight; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: C LF178P 05 01; 2005-000548-98