Effect of Fenofibrate on Sleep Apnea Syndrome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Dyslipidemia Sleep Apnea Syndrome Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Fenofibrate-matching placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Fenofibrate-matching placebo tablet

2

145 mg NanoCrystal fenofibrate tablet

Group Type EXPERIMENTAL

Fenofibrate

Intervention Type DRUG

145 mg NanoCrystal tablet

Interventions

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Placebo

Fenofibrate-matching placebo tablet

Intervention Type DRUG

Fenofibrate

145 mg NanoCrystal tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No