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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 pectoris
MedDRA version: 14.1Level: LLTClassification code 10049194Term: Stable angina pectorisSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
EUCTR2006-005475-17-IE
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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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