ong-term (3 years) ophthalmic safety and cardiac efficacy and safety of ivabradine administered orally at the therapeutic doses (2.5/5/7.5 mg twice daily (b.i.d.)) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris.
- Conditions
- Stable angina pectorisMedDRA version: 15.0Level: LLTClassification code 10049194Term: Stable angina pectorisSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2006-005475-17-BE
- Lead Sponsor
- Institut de Recherches Internationales Servier (I.R.I.S.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
- Male or female,
- > 18 years or legal age of majority,
- History of chronic stable angina pectoris for at least 3 months prior to pre-selection,
- Sinus rhythm and resting heart rate >= 60 bpm on a recent resting standard 12-lead ECG,
- Distant visual acuity > 0.5 with the best refraction correction in any eye.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 52
- Astigmatism > 3.00 diopters in either eye,
- Myopia > - 5.00 diopters in either eye,
- Hyperopia > + 5.00 diopters in either eye,
- Closed angle glaucoma,
- Contra-indication to the administration of ivabradine.
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