Safety of oral chronic administration of ivabradine modified release formulation compared to ivabradine immediate release formulation, in patients with stable coronary artery disease

• Conditions: Stable coronary artery disease; MedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001668-31-SK
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-15
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

- Women or men;
- Age = 18 years;
- Documented stable CAD with or without chronic stable angina pectoris;
- Normal sinus rhythm;
- Resting heart rate = 60bpm.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 374
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 326

Exclusion Criteria

- Women who are pregnant, breast-feeding or women of childbearing potential not using
estro-progestative oral or intra-uterine contraception or implants, or women using estroprogestative or intra-uterine contraception or implants but who consider stopping it during the planned duration of the study.
- Contra-indication to ivabradine, ivabradine not recommended or not effective, or requirement for a not recommended concomitant treatment (cf ivabradine SmPC)
- Heart failure patients with NYHA functional classification II, III or IV.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified