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

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ClinicalTrials.gov Identifier: NCT00202566
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 15, 2018
Sponsor:
Information provided by:
Servier

September 12, 2005
September 20, 2005
March 15, 2018
June 2005
Not Provided
Improvement between baseline and end of treatment of the treadmill exercise tolerance test
Same as current
Complete list of historical versions of study NCT00202566 on ClinicalTrials.gov Archive Site
  • Rate pressure product
  • Clinical evaluation
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
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.
To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Angina Pectoris
Drug: Ivabradine
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
Same as current
October 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00202566
CL3-16257-057
Not Provided
Not Provided
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Not Provided
Institut de Recherches Internationales Servier
Not Provided
Study Chair: Jean-Claude Tardif, Pr Montreal Heart Institute
Servier
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP