Evaluation of the anti-anginal efficacy and safety of oral administration of ivabradine compared to placebo on top of a background therapy with atenolol in patients with stable angina pectoris.A 4-month randomised double-blind parallel-group international multicentre study.

Phase 1

• Conditions: stable angina pectoris; MedDRA version: 7.0Level: PTClassification code 10002383

• Registration Number: EUCTR2004-001960-30-SK
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-16
• Last Update Posted: 20 February 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Patients to be selected will be male or female outpatients between 18 (or the legal age) and 75 years with a history of stable angina pectoris (duration >or= 3 months) with no angina at rest and no angina of class IV of the Canadian Cardiovascular Society classification, treated by atenolol 50 mg o.d. or by any other beta-blocker at equivalent dosage (duration of treatment >or= 3 months) and who still present a positive ETT or symptomatic angina in everyday life. Heart rate (ECG) at rest with atenolol (50 mg o.d.) must be >or= 60 bpm at pre-selection and inclusion. Patients to be included should have three positive exercise tolerance tests (limiting angina pain + ST depression >or= 1 mm within 3 min to 12 min) and stable exercise tolerance test (time to 1 mm ST segment depressions between second selection visit and inclusion visit ETT must be within ± 20% or ±1 min of each other) during the run-in period.
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

Exclusion Criteria

- Modification of a selection criteria that would prevent the patient of being included.
- Any clinical deterioration during the run-in period, as demonstrated by a significant increase in the mean number of anginal attacks per week and by a significant increase in the mean nitrates consumption per week (increase by more than 5 in the mean number of angina attacks per week and by more than 50% respectively between SEL1 and M0 visits).
- HR < 60 bpm measured on ECG at rest.
- Compliance to atenolol and placebo < 75% or > 130%.
- Patient having stopped the ETT preceding inclusion before reaching the positivity criteria for one of the reasons listed in appendix 4 as criteria for early interruption of the exercise test.
- Non stability in ST segment depression.
- Abnormalities in the laboratory blood tests performed at SEL2 considered to be dangerous for the patient if he/she continued in the study:
- severe renal failure (serum creatinine > 200 micromoles per litre),
- severe liver function test abnormalities: ALAT or ASAT > 3 times the upper normal values,
- electrolyte disorders, particularly kaliema < 3.5 mmol/l or > 5.2 mmol/l,
- significant anaemia defined as blood haemoglobin lower than 110 grams per litre (in males) or lower than 100 grams per litre (in females).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified