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 b.i.d.) on top of anti-anginal background therapy, to patients with chronic stable angina pectoris. An international, double-blind placebo controlled study.
- Conditions
- Stable angina pectorisMedDRA version: 9.1 Level: LLT Classification code 10049194 Term: Stable angina pectoris
- Registration Number
- EUCTR2006-005475-17-GB
- 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
- Not specified
- Target Recruitment
- 97
- 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- 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 Main Objective: - To document the absence of retinal toxicity of ivabradine versus placebo in chronic stable angina patients after treatment cessation in the subset of patients with emergent bilateral relevant ERG abnormalities observed under treatment at M36.;<br> Secondary Objective: To document :<br> - the evolution of ophthalmic parameters at M36 and at M38 as compared to the baseline values, at M38/M36 and versus placebo,<br> - the evolution over time of ophthalmic tests results,<br> - the long-term ophthalmic safety on ocular events,<br> - the cardiac long-term efficacy,<br> - the absence of potential rebound phenomenon,<br> - the long-term general safety on adverse events, vital signs, blood pressure, ECG abnormalities and on haematology/biochemistry analyses.<br> ;Primary end point(s): Ophthalmic safety measurements.
- Secondary Outcome Measures
Name Time Method