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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-000548-98 |
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The study was prematurely terminated because of slow recruitment
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Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Fenofibrate-matching placebo tablet |
|
| 2 | Experimental | 145 mg NanoCrystal fenofibrate tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Fenofibrate-matching placebo tablet |
| |
| Fenofibrate |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at one month of treatment |
| 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. | at 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. | at one month of treatment |
| 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 | at 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. | at 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. | at one month of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 1 | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20297950 | Derived | 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. |
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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.
Subjects were recruited and treated in a hospital in Paris between September 2005 and January 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo |
| FG001 | Fenofibrate | Fenofibrate 145 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo |
| BG001 | Fenofibrate | Fenofibrate 145 mg |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | The analysis was performed using the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number of obstructive apneas | at one month of treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Metabolic and medical procedures | Surgical and medical procedures | MedDRA 10.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sven Voet, Global Communication | Solvay Pharmaceuticals | +32 (0) 2 509 69 77 | sven.voet@solvay.com |
Not provided
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D012891 | Sleep Apnea Syndromes |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001049 | Apnea |
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| ID | Term |
|---|---|
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Drug |
145 mg NanoCrystal tablet |
|
| 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. | at 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. | at one month of treatment |
| Index of Apneas | Average number of apneas per hour of sleep during one night after one month of treatment. | at one month of treatment |
| Index of Hypopneas | Average number of hypopneas per hour of sleep during one night after one month of treatment. | at one month of treatment |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | 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. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 in fenofibrate). | Posted | Median | Full Range | Number of desaturations | at one month of treatment |
|
|
|
|
| Primary | 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. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Percentage of sleep time | at one month of treatment |
|
|
|
|
| Primary | 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 | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number of apneas | at one month of treatment |
|
|
|
|
| Primary | 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. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number of hypopneas | at one month of treatment |
|
|
|
|
| Primary | Index Apnea/Hypopnea | Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number per hour of sleep | at one month of treatment |
|
|
|
|
| Primary | 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. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number of mixed apneas | at one month of treatment |
|
|
|
|
| Primary | 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. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number of central apneas | at one month of treatment |
|
|
|
|
| Primary | Index of Apneas | Average number of apneas per hour of sleep during one night after one month of treatment. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number per hour of sleep | at one month of treatment |
|
|
|
|
| Primary | Index of Hypopneas | Average number of hypopneas per hour of sleep during one night after one month of treatment. | The analysis was performed on the total sample of randomized subjects (16 on placebo and 18 on fenofibrate). | Posted | Median | Full Range | Number per hour of sleep | at one month of treatment |
|
|
|
|
| 0 |
| 1 |
| EG001 | Fenofibrate | Fenofibrate 145 mg | 1 | 3 |
| Cystitis | Infections and infestations | MedDRA 10.1 | Non-systematic Assessment |
|
| Diabetes mellitus non-insulin-dependent | Metabolism and nutrition disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.1 | Non-systematic Assessment |
|
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.
| D012120 |
| Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |