Back to results

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

Primary Purpose

Heart Failure, Sleep Apnea Syndromes, Cheyne-Stokes Respiration

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AVE0657

placebo

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Cheyne-stokes breathing

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Dose Level 1

Dose Level 2

Dose Level 3

Dose Level 4

Placebo

Arm Description

12 subjects: 3 subjects per dose level

Outcomes

Primary Outcome Measures

Change in the Apnea Hypopnea Index (AHI)

Secondary Outcome Measures

Safety and tolerability

Full Information

NCT ID

NCT00694720

First Posted

May 7, 2008

Last Updated

April 30, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00694720

Brief Title

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

Official Title

A Double-Blind, Randomized, Placebo-Controlled, Study Evaluating the Safety and Activity of Four Escalating Single Doses of AVE0657 in Congestive Heart Failure Patients Presenting as Cheyne-Stokes Breathing Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Terminated

Why Stopped

Termination following reassessment of the potential benefit-risk of AVE0657

Study Start Date

June 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Sleep Apnea Syndromes, Cheyne-Stokes Respiration

Keywords

Cheyne-stokes breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose Level 1

Arm Type

Experimental

Arm Title

Dose Level 2

Arm Type

Experimental

Arm Title

Dose Level 3

Arm Type

Experimental

Arm Title

Dose Level 4

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

12 subjects: 3 subjects per dose level

Intervention Type

Drug

Intervention Name(s)

AVE0657

Intervention Description

capsules once a day at bedtime

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

capsules once a day at bedtime

Primary Outcome Measure Information:

Title

Change in the Apnea Hypopnea Index (AHI)

Time Frame

2 days

Secondary Outcome Measure Information:

Title

Safety and tolerability

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick LEVY, Professor

Organizational Affiliation

Hôpital Michallon - Grenoble - France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Paris

Country

France

Facility Name

Sanofi-Aventis Administrative Office

City

Berlin

Country

Germany

Facility Name

Sanofi-Aventis Administrative Office

City

Barcelona

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs