Trial Outcomes & Findings for Effect of Fenofibrate on Sleep Apnea Syndrome (NCT NCT00816829)

NCT ID: NCT00816829

Last Updated: 2009-07-22

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

at one month of treatment

Results posted on

2009-07-22

Participant Flow

Subjects were recruited and treated in a hospital in Paris between September 2005 and January 2008

In total 34 subjects were randomly allocated to treatment (i.e. Subjects Started). All the subjects received the study drug and completed the study. The study was prematurely terminated because of low recruitment.

Participant milestones

Participant milestones
Measure	Placebo Placebo	Fenofibrate Fenofibrate 145 mg
Overall Study STARTED	16	18
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Fenofibrate on Sleep Apnea Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg	Total n=34 Participants Total of all reporting groups
Age Continuous	55.2 years STANDARD_DEVIATION 6.5 • n=5 Participants	55.9 years STANDARD_DEVIATION 5.4 • n=7 Participants	55.6 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment France	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

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).

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Obstructive Apneas	30.5 Number of obstructive apneas Interval 0.0 to 318.0	15.0 Number of obstructive apneas Interval 0.0 to 168.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate).

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.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Desaturations	171.0 Number of desaturations Interval 61.0 to 674.0	130.0 Number of desaturations Interval 14.0 to 219.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

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.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Sleep Time With Oxygen Saturation Below 90%	11.5 Percentage of sleep time Interval 3.0 to 60.0	3.5 Percentage of sleep time Interval 0.0 to 49.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

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

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Apneas	31.0 Number of apneas Interval 0.0 to 617.0	20.5 Number of apneas Interval 0.0 to 268.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

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.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Hypopneas	69.5 Number of hypopneas Interval 32.0 to 222.0	63.0 Number of hypopneas Interval 1.0 to 179.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Index Apnea/Hypopnea	22.5 Number per hour of sleep Interval 4.0 to 114.0	17.0 Number per hour of sleep Interval 0.0 to 47.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

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.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Mixed Apneas	0.0 Number of mixed apneas Interval 0.0 to 220.0	1.0 Number of mixed apneas Interval 0.0 to 28.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

Total number of central apneas (i.e. apneas with no respiratory effort present) during sleep during one night after one month of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Central Apneas	0.0 Number of central apneas Interval 0.0 to 68.0	1.0 Number of central apneas Interval 0.0 to 46.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

Average number of apneas per hour of sleep during one night after one month of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Index of Apneas	4.0 Number per hour of sleep Interval 0.0 to 105.0	2.5 Number per hour of sleep Interval 0.0 to 45.0

PRIMARY outcome

Timeframe: at one month of treatment

Population: The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate).

Average number of hypopneas per hour of sleep during one night after one month of treatment.

Outcome measures

Outcome measures
Measure	Placebo n=16 Participants Placebo	Fenofibrate n=18 Participants Fenofibrate 145 mg
Index of Hypopneas	11.0 Number per hour of sleep Interval 4.0 to 31.0	9.5 Number per hour of sleep Interval 0.0 to 33.0

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Fenofibrate

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Placebo	Fenofibrate Fenofibrate 145 mg
Surgical and medical procedures Metabolic and medical procedures	0.00% 0/16	5.6% 1/18

Other adverse events

Other adverse events
Measure	Placebo Placebo	Fenofibrate Fenofibrate 145 mg
Musculoskeletal and connective tissue disorders Back Pain	6.2% 1/16	0.00% 0/18
Infections and infestations Cystitis	0.00% 0/16	5.6% 1/18
Metabolism and nutrition disorders Diabetes mellitus non-insulin-dependent	0.00% 0/16	5.6% 1/18
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	0.00% 0/16	5.6% 1/18
Skin and subcutaneous tissue disorders Rash	0.00% 0/16	5.6% 1/18
Gastrointestinal disorders Abdominal distension	0.00% 0/16	5.6% 1/18

Additional Information

Sven Voet, Global Communication

Solvay Pharmaceuticals

Phone: +32 (0) 2 509 69 77

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review.
Publication restrictions are in place

Restriction type: OTHER