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

• ClinicalTrials.gov Identifier: NCT00694720
• Recruitment Status: Terminated
• First Posted: June 10, 2008
• Last Update Posted: May 1, 2009
• Sponsor: Sanofi
• Information provided by: Sanofi

Tracking Information

• First Submitted Date: May 7, 2008
• First Posted Date: June 10, 2008
• Last Update Posted Date: May 1, 2009
• Study Start Date: June 2008
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 6, 2008): Change in the Apnea Hypopnea Index (AHI) [ Time Frame: 2 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: June 6, 2008): Safety and tolerability [ Time Frame: 5 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Heart Failure
• Sleep Apnea Syndromes
• Cheyne-Stokes Respiration

Intervention

• Drug: AVE0657
  capsules once a day at bedtime
• Drug: placebo
  capsules once a day at bedtime

Study Arms

• Experimental: Dose Level 1
  Intervention: Drug: AVE0657
• Experimental: Dose Level 2
  Intervention: Drug: AVE0657
• Experimental: Dose Level 3
  Intervention: Drug: AVE0657
• Experimental: Dose Level 4
  Intervention: Drug: AVE0657
• Placebo Comparator: Placebo
  12 subjects: 3 subjects per dose level
  Intervention: Drug: placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 30, 2009): 8
• Original Estimated Enrollment (submitted: June 6, 2008): 36
• Actual Study Completion Date: March 2009
• Actual Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Spain

Administrative Information

• NCT Number: NCT00694720
• Other Study ID Numbers: ACT6795; EudraCT 2007-002172-34
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: ICD Study Director, sanofi-aventis
• Study Sponsor: Sanofi
• Collaborators: Not Provided

Investigators

• Principal Investigator: Patrick LEVY, Professor; Hôpital Michallon - Grenoble - France

• PRS Account: Sanofi
• Verification Date: April 2009