Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 2:13 PM
Study NCT ID:
NCT00202566
Status:
COMPLETED
Last Update Posted:
2018-03-15
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077550', 'term': 'Ivabradine'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-13', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement between baseline and end of treatment of the treadmill exercise tolerance test'}], 'secondaryOutcomes': [{'measure': 'Rate pressure product'}, {'measure': 'Clinical evaluation'}]}, 'conditionsModule': {'conditions': ['Angina Pectoris']}, 'referencesModule': {'references': [{'pmid': '19136486', 'type': 'RESULT', 'citation': 'Tardif JC, Ponikowski P, Kahan T; ASSOCIATE Study Investigators. Efficacy of the I(f) current inhibitor ivabradine in patients with chronic stable angina receiving beta-blocker therapy: a 4-month, randomized, placebo-controlled trial. Eur Heart J. 2009 Mar;30(5):540-8. doi: 10.1093/eurheartj/ehn571. Epub 2009 Jan 9.'}]}, 'descriptionModule': {'briefSummary': 'To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic stable angina pectoris\n* Documented coronary artery disease\n* Previous treatment with atenolol or other beta-blocker agent\n* Exercise tolerance test positivity and stability\n\nExclusion Criteria:\n\n* Heart rate \\< 60 bpm\n* Congestive heart failure'}, 'identificationModule': {'nctId': 'NCT00202566', 'acronym': 'ASSOCIATE', 'briefTitle': 'Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier'}, 'officialTitle': 'Evaluation of the Anti-anginal Efficacy and Safety of Oral Administration of Ivabradine Compared to Placebo on Top of Background Therapy With Atenolol in Patients With Stable Angina Pectoris. A Four-month Randomised Double-blind, Parallel Group International Multicentre Study.', 'orgStudyIdInfo': {'id': 'CL3-16257-057'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ivabradine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jean-Claude Tardif, Pr', 'role': 'STUDY_CHAIR', 'affiliation': 'Montreal Heart Institute'}]}, 'ipdSharingStatementModule': {'url': 'http://clinicaltrials.servier.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After Marketing Authorisation in EEA or US if the study is used for the approval.', 'ipdSharing': 'YES', 'description': 'Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).\n\nThey can ask all interventional clinical studies:\n\n* submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).\n* Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.', 'accessCriteria': 'Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Recherches Internationales Servier', 'class': 'OTHER'}}}}