Effect of Fenofibrate on Sleep Apnea Syndrome

Phase 2TerminatedNCT00816829

Solvay Pharmaceuticals34 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Dyslipidemia Sleep Apnea Syndrome Overweight Obesity

Interventions

PlaceboDRUG

Fenofibrate-matching placebo tablet

FenofibrateDRUG

145 mg NanoCrystal tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Site 1

Paris, France

Outcomes

Primary Outcomes

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).