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

This study has been completed.
Sponsor:
Information provided by:
Servier
ClinicalTrials.gov Identifier:
NCT00202566
First received: September 12, 2005
Last updated: June 15, 2011
Last verified: June 2011
History of Changes
  Purpose

To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris


Condition Intervention Phase
Angina Pectoris
 Drug: Ivabradine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

Drug Information available for: Atenolol
U.S. FDA Resources

Further study details as provided by Servier:

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

Secondary Outcome Measures:
  • Rate pressure product
  • Clinical evaluation

Estimated Enrollment: 750
Study Start Date: June 2005
Study Completion Date: October 2007
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202566

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

No publications provided

ClinicalTrials.gov Identifier: NCT00202566     History of Changes
Other Study ID Numbers: CL3-16257-057
Study First Received: September 12, 2005
Last Updated: June 15, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Atenolol
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Antihypertensive Agents
Sympatholytics
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

ClinicalTrials.gov processed this record on May 21, 2013