Evaluation of the Effect of AVE0657 in Cheynes-Stokes Bre... | NCT00694720

Studies
Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients

NCT00694720

Sponsor

Sanofi

Status

Terminated

Last Update Posted

May 1, 2009Estimated

Enrollment

8Actual

Phase

Phase 2

Conditions

Heart Failure
Sleep Apnea Syndromes
Cheyne-Stokes Respiration

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 2007-002172-34

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Termination following reassessment of the potential benefit-risk of AVE0657

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

May 7, 2008

First Submission Date that Met QC Criteria

Jun 6, 2008

First Posted Date

Jun 10, 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

Apr 30, 2009

Last Update Posted Date

May 1, 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 on breathing parameters of 4 escalating doses of AVE0657 in comparison to placebo in patients with Cheynes-Stokes Breathing 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

8Actual

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 the Apnea Hypopnea Index (AHI)		2 days

Measure	Description	Time Frame
Safety and tolerability		5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of Congestive heart failure (CHF) defined as ejection fraction ≤40% by history of echocardiography data and New York heart Association (NYHA) class II-III and of typical cyclic crescendo and decrescendo change in breathing amplitude AHI ≥10 and <60 and majority of the apneas to be ≥60% central in origin.

Exclusion Criteria:

Subject on supplemental oxygen

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
D006333	Heart Failure
D012891	Sleep Apnea Syndromes
D002639	Cheyne-Stokes Respiration

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001049	Apnea
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided