Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
ASSOCIATE
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.
1 other identifier
interventional
750
1 country
1
Brief Summary
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 15, 2018
March 1, 2018
September 12, 2005
March 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement between baseline and end of treatment of the treadmill exercise tolerance test
Secondary Outcomes (2)
Rate pressure product
Clinical evaluation
Interventions
Eligibility Criteria
You may qualify if:
- Chronic stable angina pectoris
- Documented coronary artery disease
- Previous treatment with atenolol or other beta-blocker agent
- Exercise tolerance test positivity and stability
You may not qualify if:
- Heart rate \< 60 bpm
- Congestive heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Related Publications (1)
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.
PMID: 19136486RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean-Claude Tardif, Pr
Montreal Heart Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
June 1, 2005
Study Completion
October 1, 2007
Last Updated
March 15, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- 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.
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * 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.