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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 product

Clinical 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

Page last updated: October 19, 2009

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