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Effect of Fenofibrate on Sleep Apnea Syndrome

Primary Purpose

Dyslipidemia, Sleep Apnea Syndrome, Overweight

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Placebo
Fenofibrate
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring Dyslipidemia, Sleep Apnea Syndromes, Fenofibrate, Obese, Overweight or obese patients

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Site 1

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

1

2

Arm Description

Fenofibrate-matching placebo tablet

145 mg NanoCrystal fenofibrate tablet

Outcomes

Primary Outcome Measures

Obstructive Apneas
Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).
Desaturations
Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.
Sleep Time With Oxygen Saturation Below 90%
Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.
Apneas
Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment
Hypopneas
Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.
Index Apnea/Hypopnea
Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Mixed Apneas
Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.
Central Apneas
Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.
Index of Apneas
Average number of apneas per hour of sleep during one night after one month of treatment.
Index of Hypopneas
Average number of hypopneas per hour of sleep during one night after one month of treatment.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2009
Last Updated
July 17, 2009
Sponsor
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00816829
Brief Title
Effect of Fenofibrate on Sleep Apnea Syndrome
Official Title
A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated because of slow recruitment
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Sleep Apnea Syndrome, Overweight, Obesity
Keywords
Dyslipidemia, Sleep Apnea Syndromes, Fenofibrate, Obese, Overweight or obese patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Fenofibrate-matching placebo tablet
Arm Title
2
Arm Type
Experimental
Arm Description
145 mg NanoCrystal fenofibrate tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Fenofibrate-matching placebo tablet
Intervention Type
Drug
Intervention Name(s)
Fenofibrate
Intervention Description
145 mg NanoCrystal tablet
Primary Outcome Measure Information:
Title
Obstructive Apneas
Description
Total number of obstructive apneas during sleep during one night after one month of treatment (i.e. an occlusion of the airways accompanied by ineffective respiratory efforts).
Time Frame
at one month of treatment
Title
Desaturations
Description
Total number of desaturation events (i.e. defined as a decrease by 3 - 4% in oxygen saturation) during sleep during one night after one month of treatment.
Time Frame
at one month of treatment
Title
Sleep Time With Oxygen Saturation Below 90%
Description
Percentage of Sleep time with oxygen saturation below 90% (measured by oximetry). Marker of consequences of apneas/hypopneas on arterial oxygenation during sleep during one night after one month of treatment. Higher percentage are worst for the patients.
Time Frame
at one month of treatment
Title
Apneas
Description
Total number of episodes of apneas (i.e. cessation of breathing for at least 10 seconds) from central, obstructive or mixed origin during sleep during one night after one month of treatment
Time Frame
at one month of treatment
Title
Hypopneas
Description
Total number of episodes of hypopneas (i.e. 50% to 80% reduction in airflow with a decrease of 3-4% in arterial oxygen saturation) during sleep during one night after one month of treatment.
Time Frame
at one month of treatment
Title
Index Apnea/Hypopnea
Description
Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Time Frame
at one month of treatment
Title
Mixed Apneas
Description
Total number of mixed apneas (i.e. sleep apneas that have both obstructive and central component) during sleep during one night after one month of treatment.
Time Frame
at one month of treatment
Title
Central Apneas
Description
Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.
Time Frame
at one month of treatment
Title
Index of Apneas
Description
Average number of apneas per hour of sleep during one night after one month of treatment.
Time Frame
at one month of treatment
Title
Index of Hypopneas
Description
Average number of hypopneas per hour of sleep during one night after one month of treatment.
Time Frame
at one month of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 1
City
Paris
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20297950
Citation
Bruckert E, Duchene E, Bonnefont-Rousselot D, Hansel B, Ansquer JC, Dubois A, Gaymard B. Proof of concept study: does fenofibrate have a role in sleep apnoea syndrome? Curr Med Res Opin. 2010 May;26(5):1185-92. doi: 10.1185/03007991003693581.
Results Reference
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Effect of Fenofibrate on Sleep Apnea Syndrome

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