Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris
Information source: Servier
Information obtained from ClinicalTrials.gov on October 19, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Angina Pectoris
Intervention: Ivabradine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Institut De Recherche International Servier Official(s) and/or principal investigator(s): Jean-Claude Tardif, Pr, Study Chair, Affiliation: Montreal Heart Institute
Overall contact: Jean-Claude Tardif, Pr, Phone: 514-376-3330
Summary
To test whether ivabradine when given in combination with atenolol is able to improve the
exercise tolerance of patients with stable angina pectoris
Clinical Details
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 design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Improvement between baseline and end of treatment of the treadmill exercise tolerance test
Secondary outcome: Rate pressure productClinical evaluation
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Jean-Claude Tardif, Pr, Phone: 514-376-3330
Montreal Heart Institute, Montreal, Quebec H1T 1C8, Canada; Recruiting
Additional Information
Starting date: June 2005
Last updated: October 2, 2006
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