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NCT00202566 Clinical Trial

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

Angina Pectoris Clinical Trial

— ASSOCIATE  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00202566
Other study ID # CL3-16257-057
Secondary ID
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated March 13, 2018
Start date June 2005
Est. completion date October 2007

Study information
Verified date March 2018
Source Servier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 750
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Ivabradine

Locations
Country Name City State
Canada Montreal Heart Institute Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Institut de Recherches Internationales Servier

Country where clinical trial is conducted

Canada, 

References & 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 Ma — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement between baseline and end of treatment of the treadmill exercise tolerance test
Secondary Rate pressure product
Secondary Clinical evaluation
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