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Effect of Fenofibrate on Sleep Apnea Syndrome

This study has been terminated.
(The study was prematurely terminated because of slow recruitment)
ClinicalTrials.gov Identifier:
First Posted: January 5, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Solvay Pharmaceuticals
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.

Condition Intervention Phase
Dyslipidemia Sleep Apnea Syndrome Overweight Obesity Drug: Placebo Drug: Fenofibrate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome

Resource links provided by NLM:

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Obstructive Apneas [ Time Frame: at one month of treatment ]
  • Desaturations [ Time Frame: at one month of treatment ]
  • Sleep Time With Oxygen Saturation Below 90% [ Time Frame: at one month of treatment ]
  • Apneas [ Time Frame: at one month of treatment ]
  • Hypopneas [ Time Frame: at one month of treatment ]
  • Index Apnea/Hypopnea [ Time Frame: at one month of treatment ]
  • Mixed Apneas [ Time Frame: at one month of treatment ]
  • Central Apneas [ Time Frame: at one month of treatment ]
  • Index of Apneas [ Time Frame: at one month of treatment ]
  • Index of Hypopneas [ Time Frame: at one month of treatment ]

Enrollment: 34
Study Start Date: September 2005
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816829

Site 1
Paris, France
Sponsors and Collaborators
Solvay Pharmaceuticals
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Claude Ansquer, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00816829     History of Changes
Other Study ID Numbers: C LF178P 05 01
First Submitted: January 2, 2009
First Posted: January 5, 2009
Results First Submitted: January 8, 2009
Results First Posted: July 7, 2009
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by Solvay Pharmaceuticals:
Sleep Apnea Syndromes
Overweight or obese patients

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Body Weight
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents