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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)
Sponsor:
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00816829
First received: January 2, 2009
Last updated: July 17, 2009
Last verified: July 2009
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Desaturations [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Sleep Time With Oxygen Saturation Below 90% [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Apneas [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Hypopneas [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Index Apnea/Hypopnea [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Mixed Apneas [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Central Apneas [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Index of Apneas [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]
  • Index of Hypopneas [ Time Frame: at one month of treatment ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816829

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

No publications provided by Solvay Pharmaceuticals

Additional 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, 2005-000548-98
Study First Received: January 2, 2009
Results First Received: January 8, 2009
Last Updated: July 17, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Apnea
Dyslipidemias
Overweight
Sleep Apnea Syndromes
Syndrome
Body Weight
Disease
Dyssomnias
Lipid Metabolism Disorders
Metabolic Diseases
Nervous System Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic
Fenofibrate
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014