Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with a calcium antagonist (amlodipine or nifedipine) in patients with stable angina pectoris.A 6-week randomised double-blind parallel-group international multicentre study.
- Conditions
- Stable angina pectorisMedDRA version: 9.1Level: PTClassification code 10002383Term: Angina pectoris
- Registration Number
- EUCTR2006-006246-34-EE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1240
- Male or female aged >= 18 years,
- History of chronic stable angina pectoris,
- Normal sinus rythm,
- Patients having been treated by amlodipine or nifedipine for at least 4 weeks before selection,
- Patients with documented coronary artery disease (CAD).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Recent acute myocardial infarction, coronary bypass surgery or percutaneous coronary intervention,
- Resting angina, unstable angina, Prinzmetal angina or microvascular angina,
- Patient with a pacemaker or implanted cardioverter-defibrillator,
- Patient who cannot perform exercise tests,
- Congestive heart failure stage III or IV NYHA, uncontrolled heart failure,
- HR < 60 bpm measured on ECG at rest at selection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method