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Effect of Fenofibrate on Sleep Apnea Syndrome

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ClinicalTrials.gov Identifier: NCT00816829
Recruitment Status : Terminated (The study was prematurely terminated because of slow recruitment)
First Posted : January 5, 2009
Results First Posted : July 7, 2009
Last Update Posted : July 22, 2009
Sponsor:
Information provided by:
Solvay Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Dyslipidemia Sleep Apnea Syndrome Overweight Obesity Drug: Placebo Drug: Fenofibrate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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
Study Start Date : September 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
Drug Information available for: Fenofibrate

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




Primary Outcome Measures :
  1. Obstructive Apneas [ Time Frame: at one month of treatment ]
  2. Desaturations [ Time Frame: at one month of treatment ]
  3. Sleep Time With Oxygen Saturation Below 90% [ Time Frame: at one month of treatment ]
  4. Apneas [ Time Frame: at one month of treatment ]
  5. Hypopneas [ Time Frame: at one month of treatment ]
  6. Index Apnea/Hypopnea [ Time Frame: at one month of treatment ]
  7. Mixed Apneas [ Time Frame: at one month of treatment ]
  8. Central Apneas [ Time Frame: at one month of treatment ]
  9. Index of Apneas [ Time Frame: at one month of treatment ]
  10. Index of Hypopneas [ Time Frame: at one month of treatment ]


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

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.

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


Locations
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France
Site 1
Paris, France
Sponsors and Collaborators
Solvay Pharmaceuticals
Investigators
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jean-Claude Ansquer, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00816829     History of Changes
Other Study ID Numbers: C LF178P 05 01
2005-000548-98
First Posted: January 5, 2009    Key Record Dates
Results First Posted: July 7, 2009
Last Update Posted: July 22, 2009
Last Verified: July 2009
Keywords provided by Solvay Pharmaceuticals:
Dyslipidemia
Sleep Apnea Syndromes
Fenofibrate
Obese
Overweight or obese patients
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Dyslipidemias
Syndrome
Overweight
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Body Weight
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents