Trial · NCT00816829

Effect of Fenofibrate on Sleep Apnea Syndrome

NCT00816829, Phase 2, Terminated, Solvay Pharmaceuticals; results first posted 2009-07-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effect of Fenofibrate on Sleep Apnea Syndrome. Trials, record NCT00816829. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00816829

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effect of Fenofibrate on Sleep Apnea Syndrome
NCT number: NCT00816829
Status: Terminated
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Solvay Pharmaceuticals
Conditions: Dyslipidemia, Sleep Apnea Syndrome, Overweight, Obesity
Interventions: Placebo, Fenofibrate
First posted: 2009-01-05
Last updated: 2009-07-22
Results first posted: 2009-07-07
Limitations and caveats: Only treatment emergent events have been presented. They are defined as events started at or after the 1st administration of study medication and includes events started prior to the 1st administration but which worsened after the 1st intake.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Obstructive Apneas	at one month of treatment	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).
Primary	Desaturations	at one month of treatment	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.
Primary	Sleep Time With Oxygen Saturation Below 90%	at one month of treatment	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.
Primary	Apneas	at one month of treatment	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
Primary	Hypopneas	at one month of treatment	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.
Primary	Index Apnea/Hypopnea	at one month of treatment	Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Primary	Mixed Apneas	at one month of treatment	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.
Primary	Central Apneas	at one month of treatment	Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.
Primary	Index of Apneas	at one month of treatment	Average number of apneas per hour of sleep during one night after one month of treatment.
Primary	Index of Hypopneas	at one month of treatment	Average number of hypopneas per hour of sleep during one night after one month of treatment.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Obstructive Apneas	at one month of treatment	The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number of obstructive apneas	MEDIAN
PRIMARY	Desaturations	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).	Number of desaturations	MEDIAN
PRIMARY	Sleep Time With Oxygen Saturation Below 90%	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Percentage of sleep time	MEDIAN
PRIMARY	Apneas	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number of apneas	MEDIAN
PRIMARY	Hypopneas	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number of hypopneas	MEDIAN
PRIMARY	Index Apnea/Hypopnea	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number per hour of sleep	MEDIAN
PRIMARY	Mixed Apneas	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number of mixed apneas	MEDIAN
PRIMARY	Central Apneas	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number of central apneas	MEDIAN
PRIMARY	Index of Apneas	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number per hour of sleep	MEDIAN
PRIMARY	Index of Hypopneas	at one month of treatment	The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).	Number per hour of sleep	MEDIAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Obstructive Apneas	Placebo	30.5	Full Range 0 to 318	Number of obstructive apneas
Obstructive Apneas	Fenofibrate	15.0	Full Range 0 to 168	Number of obstructive apneas
Desaturations	Placebo	171.0	Full Range 61.0 to 674.0	Number of desaturations
Desaturations	Fenofibrate	130.0	Full Range 14.0 to 219.0	Number of desaturations
Sleep Time With Oxygen Saturation Below 90%	Placebo	11.5	Full Range 3.0 to 60.0	Percentage of sleep time
Sleep Time With Oxygen Saturation Below 90%	Fenofibrate	3.5	Full Range 0.0 to 49.0	Percentage of sleep time
Apneas	Placebo	31.0	Full Range 0 to 617	Number of apneas
Apneas	Fenofibrate	20.5	Full Range 0 to 268	Number of apneas
Hypopneas	Placebo	69.5	Full Range 32.0 to 222.0	Number of hypopneas
Hypopneas	Fenofibrate	63.0	Full Range 1.0 to 179.0	Number of hypopneas

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	16
Overall Study	STARTED	Fenofibrate	18
Overall Study	COMPLETED	Placebo	16
Overall Study	COMPLETED	Fenofibrate	18
Overall Study	NOT COMPLETED	Placebo	0
Overall Study	NOT COMPLETED	Fenofibrate	0

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	1	16
other	Back Pain	Musculoskeletal and connective tissue disorders	Fenofibrate	0	18
other	Cystitis	Infections and infestations	Placebo	0	16
other	Cystitis	Infections and infestations	Fenofibrate	1	18
other	Diabetes mellitus non-insulin-dependent	Metabolism and nutrition disorders	Placebo	0	16
other	Diabetes mellitus non-insulin-dependent	Metabolism and nutrition disorders	Fenofibrate	1	18
other	Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	Placebo	0	16
other	Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	Fenofibrate	1	18
other	Rash	Skin and subcutaneous tissue disorders	Placebo	0	16
other	Rash	Skin and subcutaneous tissue disorders	Fenofibrate	1	18

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected
Total, all-cause mortality	Placebo
Total, all-cause mortality	Fenofibrate
Total, other adverse events	Placebo	1
Total, other adverse events	Fenofibrate	3
Total, serious adverse events	Placebo	0
Total, serious adverse events	Fenofibrate	1

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
20297950	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00816829

GET https://conductscience.org/api/trials/v1/NCT00816829/registered

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