Long-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

Long-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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005475-17-IE

Enrollment

100

Registered

2007-10-16

Start date

2008-01-04

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable angina pectoris MedDRA version: 14.1 Level: LLT Classification code 10049194 Term: Stable angina pectoris System Organ Class: 10007541 - Cardiac disorders

Interventions

Product Name: S16257 Product Code: S16257 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ivabradine CAS Number: 155974-00-8 Current Sponsor code: S16257 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: To document : - the evolution of ophthalmic parameters at M36 and at M38 as compared to the baseline values, at M38/M36 and versus placebo, - the evolution over time of ophthalmic tests results, - the long-term ophthalmic safety on ocular events, - the cardiac long-term efficacy, - the absence of potential rebound phenomenon, - the long-term general safety on adverse events, vital signs, blood pressure, ECG abnormalities and on haematology/biochemistry analyses.;Primary end point(s): the absence of retinal toxicity in chronic stable angina patients assessed by ocular tests performed 2 months after a treatment exposure of 3 years;Timepoint(s) of evaluation of this end point: 2 months after a treatment exposure of 3 years	—

Measure

Time frame

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.;Secondary Objective: To document : - the evolution of ophthalmic parameters at M36 and at M38 as compared to the baseline values, at M38/M36 and versus placebo, - the evolution over time of ophthalmic tests results, - the long-term ophthalmic safety on ocular events, - the cardiac long-term efficacy, - the absence of potential rebound phenomenon, - the long-term general safety on adverse events, vital signs, blood pressure, ECG abnormalities and on haematology/biochemistry analyses.;Primary end point(s): the absence of retinal toxicity in chronic stable angina patients assessed by ocular tests performed 2 months after a treatment exposure of 3 years;Timepoint(s) of evaluation of this end point: 2 months after a treatment exposure of 3 years

—

Secondary

Measure	Time frame
Secondary end point(s): the long term cardiac efficacy and general ocular, cardiac and general safety ;Timepoint(s) of evaluation of this end point: over the study	—

Countries

Argentina, Australia, Belgium, Finland, Germany, Hungary, Ireland, Portugal, Singapore, Sweden, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+331 55 72 43 66

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026