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

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. - NA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006246-34-LV

Enrollment

1240

Registered

2007-10-09

Start date

2007-11-28

Completion date

Unknown

Last updated

2012-09-25

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: PT Classification code 10002383 Term: Angina pectoris System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: PROCORALAN 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 Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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) no F.1.2.1 Number of subjects for this age range 682 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 558

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To demonstrate that over a 6-week treatment period ivabradine is more efficacious than placebo when given in combination with calcium antagonists (amlodipine or nifedipine) in patients with stable chronic effort angina pectoris.;Secondary Objective: - To demonstrate the superiority of ivabradine versus placebo when given in combination with calcium antagonists (amlodipine or nifedipine) on the change of ETT criteria at the trough and at the peak of ivabradine activity over a 6-week treatment period and on the change in the mean number of angina attacks per week, - To compare the change in the mean consumption of short acting nitrate per week between ivabradine and placebo when given in combination with calcium antagonists (amlodipine or nifedipine) over a 6-week treatment period, - To assess the change of HR and RPP over a 6-week treatment period of ivabradine versus placebo when given in combination with calcium antagonists (amlodipine or nifedipine) at the trough and at the peak of ivabradine activity, - To compare the safety and tolerability profile of ivabradine to placebo when given in combination with calcium antagonists (amlodipine or nifedipine) over a 6-week treatment period.;Primary end point(s): The response to treatment, evaluated over a 6-week treatment period and defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill exercise tolerance test (ETT).;Timepoint(s) of evaluation of this end point: evaluated over a 6-week treatment period	—

Measure

Time frame

Main Objective: - To demonstrate that over a 6-week treatment period ivabradine is more efficacious than placebo when given in combination with calcium antagonists (amlodipine or nifedipine) in patients with stable chronic effort angina pectoris.;Secondary Objective: - To demonstrate the superiority of ivabradine versus placebo when given in combination with calcium antagonists (amlodipine or nifedipine) on the change of ETT criteria at the trough and at the peak of ivabradine activity over a 6-week treatment period and on the change in the mean number of angina attacks per week, - To compare the change in the mean consumption of short acting nitrate per week between ivabradine and placebo when given in combination with calcium antagonists (amlodipine or nifedipine) over a 6-week treatment period, - To assess the change of HR and RPP over a 6-week treatment period of ivabradine versus placebo when given in combination with calcium antagonists (amlodipine or nifedipine) at the trough and at the peak of ivabradine activity, - To compare the safety and tolerability profile of ivabradine to placebo when given in combination with calcium antagonists (amlodipine or nifedipine) over a 6-week treatment period.;Primary end point(s): The response to treatment, evaluated over a 6-week treatment period and defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill exercise tolerance test (ETT).;Timepoint(s) of evaluation of this end point: evaluated over a 6-week treatment period

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Secondary

Measure	Time frame
Secondary end point(s): Changes in other classical exercise tolerance test parameters (secondary efficacy criteria): 1. Change over a 6-week treatment period in all the ETT criteria (TED, TST 1mm, TAO, TLA, HR and RPP) at trough (i.e. 12 ± 1 hours post-dosing) and at peak (i.e. 3 ± 1 hours postdosing) of ivabradine activity 2. Response to TST 1 mm criterion defined as an increase over a 6-week treatment period in the time to 1 mm ST segment depression of at least 60 sec, at the trough of ivabradine activity (i.e. 12 ± 1 hours post-dosing) and 24 ± 2 hours after amlodipine or nifedipine on centrally read values. 3. Response to angina attack criterion defined as a decrease of at least 3 angina attacks per week over a 6-week treatment period. 4. Clinical evolution of anginal disease (mean number of angina attacks per week, mean short acting nitrates consumption per week over a 6-week treatment period);Timepoint(s) of evaluation of this end point: evaluated over a 6-week treatment period	—

Measure

Time frame

Secondary end point(s): Changes in other classical exercise tolerance test parameters (secondary efficacy criteria): 1. Change over a 6-week treatment period in all the ETT criteria (TED, TST 1mm, TAO, TLA, HR and RPP) at trough (i.e. 12 ± 1 hours post-dosing) and at peak (i.e. 3 ± 1 hours postdosing) of ivabradine activity 2. Response to TST 1 mm criterion defined as an increase over a 6-week treatment period in the time to 1 mm ST segment depression of at least 60 sec, at the trough of ivabradine activity (i.e. 12 ± 1 hours post-dosing) and 24 ± 2 hours after amlodipine or nifedipine on centrally read values. 3. Response to angina attack criterion defined as a decrease of at least 3 angina attacks per week over a 6-week treatment period. 4. Clinical evolution of anginal disease (mean number of angina attacks per week, mean short acting nitrates consumption per week over a 6-week treatment period);Timepoint(s) of evaluation of this end point: evaluated over a 6-week treatment period

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Countries

Argentina, Armenia, Brazil, Bulgaria, Chile, Estonia, Hungary, India, Korea, Republic of, Latvia, Lithuania, Mexico, Moldova, Republic of, Peru, Philippines, Poland, Serbia, Tunisia, Ukraine

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33155 72 43 66

Outcome results

None listed

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