DyslipidemiaPhase 2NCT00816829
Effect of Fenofibrate on Sleep Apnea Syndrome
A Phase 2 study testing Fenofibrate in people with Dyslipidemia and Sleep Apnea Syndrome, run by Solvay Pharmaceuticals at 1 site in France.
Trial summary
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dyslipidemia, Sleep Apnea Syndrome, Overweight
- What is being tested?
- Fenofibrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jan 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.
- Conditions
- Dyslipidemia, Sleep Apnea Syndrome, Overweight, Obesity
- Being tested
- Placebo, Fenofibrate
- Keywords
- Dyslipidemia, Sleep Apnea Syndromes, Fenofibrate, Obese, Overweight or obese patients
- Medical subject headings
- Dyslipidemias, Sleep Apnea Syndromes, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Fenofibrate-matching placebo tablet
FenofibrateDrug
145 mg NanoCrystal tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Fenofibrate-matching placebo tablet Receives: Drug: Placebo |
| 2 | Experimental | 145 mg NanoCrystal fenofibrate tablet Receives: Drug: Fenofibrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: at 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.
Measured: 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.
Measured: at one month of treatment
Index of Apneas
Average number of apneas per hour of sleep during one night after one month of treatment.
Measured: at one month of treatment
Index of Hypopneas
Average number of hypopneas per hour of sleep during one night after one month of treatment.
Measured: at one month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startSep 2005
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: The study was prematurely terminated because of slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816829
- Sponsor's protocol ID
- C LF178P 05 01
- Other IDs
- 2005-000548-98, 2005
- Status last verified
- Jul 2009
- First submitted
- 2 Jan 2009
- Last updated
- 22 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20297950
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-month, Randomized, Double-blind, Placebo-controlled Study of Fenofibrate 145 mg Tablet in Patients With Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00816829
- Acronym / sponsor ID
- C LF178P 05 01
- Conditions
- Dyslipidemia, Sleep Apnea Syndrome, Overweight, Obesity
- Keywords
- Dyslipidemia, Sleep Apnea Syndromes, Fenofibrate, Obese, Overweight or obese patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was prematurely terminated because of slow recruitment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Posted 7 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboFenofibrate-matching placebo tablet |
| 2 | Experimental | Drug: Fenofibrate145 mg NanoCrystal fenofibrate tablet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboFenofibrate-matching placebo tablet | Drug | 1 |
| Fenofibrate145 mg NanoCrystal tablet | Drug | 2 |
Primary outcome
Obstructive Apneas
Time frame: 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).
Desaturations
Time frame: 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.
Sleep Time With Oxygen Saturation Below 90%
Time frame: 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.
Apneas
Time frame: 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
Hypopneas
Time frame: 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.
Index Apnea/Hypopnea
Time frame: at one month of treatment
Average number of apneas and/or hypopneas per hour of sleep during one night after one month of treatment.
Mixed Apneas
Time frame: 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.
Central Apneas
Time frame: 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.
Index of Apneas
Time frame: at one month of treatment
Average number of apneas per hour of sleep during one night after one month of treatment.
Index of Hypopneas
Time frame: at one month of treatment
Average number of hypopneas per hour of sleep during one night after one month of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20297950Bruckert 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fenofibrate in people with Dyslipidemia and Sleep Apnea Syndrome, run by Solvay Pharmaceuticals at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obstructive Apneas (time frame: at one month of treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00816829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2009.