Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT00694720
Status:
TERMINATED
Last Update Posted:
2009-05-01
First Post:
2008-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D002639', 'term': 'Cheyne-Stokes Respiration'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'Termination following reassessment of the potential benefit-risk of AVE0657', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-04-30', 'studyFirstSubmitDate': '2008-05-07', 'studyFirstSubmitQcDate': '2008-06-06', 'lastUpdatePostDateStruct': {'date': '2009-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Apnea Hypopnea Index (AHI)', 'timeFrame': '2 days'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cheyne-stokes breathing'], 'conditions': ['Heart Failure', 'Sleep Apnea Syndromes', 'Cheyne-Stokes Respiration']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Subject on supplemental oxygen\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00694720', 'briefTitle': 'Evaluation of the Effect of AVE0657 in Cheynes-Stokes Breathing Syndrome Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'ACT6795'}, 'secondaryIdInfos': [{'id': 'EudraCT 2007-002172-34'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Level 1', 'interventionNames': ['Drug: AVE0657']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 2', 'interventionNames': ['Drug: AVE0657']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 3', 'interventionNames': ['Drug: AVE0657']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Level 4', 'interventionNames': ['Drug: AVE0657']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '12 subjects: 3 subjects per dose level', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'AVE0657', 'type': 'DRUG', 'description': 'capsules once a day at bedtime', 'armGroupLabels': ['Dose Level 1', 'Dose Level 2', 'Dose Level 3', 'Dose Level 4']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'capsules once a day at bedtime', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Patrick LEVY, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Michallon - Grenoble - France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'ICD Study Director', 'oldOrganization': 'sanofi-aventis'}}}}