Evaluation of the Effect of AVE0657 on Obstructive Sleep... | NCT00614250

Studies
Evaluation of the Effect of AVE0657 on Obstructive Sleep Apnea

NCT00614250

Sponsor

Sanofi

Status

Completed

Last Update Posted

Jul 20, 2009Estimated

Enrollment

38Actual

Phase

Phase 2

Conditions

Sleep Apnea, Obstructive

Interventions

AVE0657
placebo

Countries

France
Germany
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT 2007-002174-58

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jan 31, 2008

First Submission Date that Met QC Criteria

Jan 31, 2008

First Posted Date

Feb 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 17, 2009

Last Update Posted Date

Jul 20, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	12 subjects: 3 subjects per dose level	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AVE0657	Drug	capsules once a day at bedtime	Dose Level 1 Dose Level 2 Dose Level 3 Dose Level 4

Measure	Description	Time Frame
Change in Apnea Hypopnea Index (AHI)		2 days

Measure	Description	Time Frame
Safety and tolerability		5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrick LEVY, Professor	Hôpital Michallon - Grenoble - France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi- Aventis Administrative Office		Paris			France
Sanofi-Aventis Administrative Office

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided