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Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris (ASSOCIATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202566
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2018
Information provided by:

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

Condition or disease Intervention/treatment Phase
Angina Pectoris Drug: Ivabradine Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: 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.
Study Start Date : June 2005
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources

Primary Outcome Measures :
  1. Improvement between baseline and end of treatment of the treadmill exercise tolerance test

Secondary Outcome Measures :
  1. Rate pressure product
  2. Clinical evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic stable angina pectoris
  • Documented coronary artery disease
  • Previous treatment with atenolol or other beta-blocker agent
  • Exercise tolerance test positivity and stability

Exclusion Criteria:

  • Heart rate < 60 bpm
  • Congestive heart failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202566

Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Sponsors and Collaborators
Institut de Recherches Internationales Servier
Study Chair: Jean-Claude Tardif, Pr Montreal Heart Institute

Additional Information:
ClinicalTrials.gov Identifier: NCT00202566     History of Changes
Other Study ID Numbers: CL3-16257-057
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://clinicaltrials.servier.com

Additional relevant MeSH terms:
Angina Pectoris
Angina, Stable
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action