Effect of Fenofibrate on Sleep Apnea Syndrome

Solvay

Status and phase: Terminated; Phase 2

Conditions: Overweight; Sleep Apnea Syndrome; Obesity; Dyslipidemia

Treatments: Drug: Fenofibrate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00816829

C LF178P 05 01

2005-000548-98

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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34 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Fenofibrate-matching placebo tablet

Treatment:

Drug: Placebo

2

Experimental group

Description:

145 mg NanoCrystal fenofibrate tablet

Treatment:

Drug: Fenofibrate