Sleep Apnea, ObstructivePhase 2NCT00614250
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea
A Phase 2 study testing AVE0657 in people with Sleep Apnea, Obstructive, run by Sanofi at 3 sites in 3 countries.
Trial summary
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- AVE0657
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jan 2008to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders
Who cannot join
- Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization
- Chronic respiratory disease or inadequate respiratory parameters
- Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m²
- Surgical procedure to correct apnea within the last three months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- AVE0657, placebo
- Keywords
- Obstructive sleep apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVE0657Drug
capsules once a day at bedtime
placeboDrug
capsules once a day at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 | Experimental | Not described Receives: Drug: AVE0657 |
| Dose Level 2 | Experimental | Not described Receives: Drug: AVE0657 |
| Dose Level 3 | Experimental | Not described Receives: Drug: AVE0657 |
| Dose Level 4 | Experimental | Not described Receives: Drug: AVE0657 |
| Placebo | Placebo comparator | 12 subjects: 3 subjects per dose level Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Apnea Hypopnea Index (AHI)
Measured: 2 days
Secondary outcomes (1)
Safety and tolerability
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Patrick LEVY, Professor, Principal investigator, Hôpital Michallon - Grenoble - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614250
- Sponsor's protocol ID
- ACT6796
- Other IDs
- EudraCT 2007-002174-58
- Status last verified
- Jul 2009
- First submitted
- 31 Jan 2008
- Last updated
- 20 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT00614250
- Acronym / sponsor ID
- ACT6796
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive sleep apnea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 | Experimental | Drug: AVE0657 |
| Dose Level 2 | Experimental | Drug: AVE0657 |
| Dose Level 3 | Experimental | Drug: AVE0657 |
| Dose Level 4 | Experimental | Drug: AVE0657 |
| Placebo | Placebo comparator | Drug: placebo12 subjects: 3 subjects per dose level |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders
Key exclusion criteria (5 listed)
- Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization
- Chronic respiratory disease or inadequate respiratory parameters
- Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m²
- Surgical procedure to correct apnea within the last three months.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| AVE0657capsules once a day at bedtime | Drug | Dose Level 1, Dose Level 2, Dose Level 3, Dose Level 4 |
| placebocapsules once a day at bedtime | Drug | Placebo |
Primary outcome
Change in Apnea Hypopnea Index (AHI)
Time frame: 2 days
1 secondary outcome
Safety and tolerability
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2009.
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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.
Patrick LEVY, Professor principal investigator
Hôpital Michallon - Grenoble - France
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVE0657 in people with Sleep Apnea, Obstructive, run by Sanofi at 3 sites in 3 countries.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 20 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 3 sites in France, Germany, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Apnea Hypopnea Index (AHI) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2009.