Condition category
Circulatory System
Date applied
26/12/2007
Date assigned
18/07/2008
Last edited
08/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Gabriel Kamensky

ORCID ID

Contact details

Faculty Hospital Ruzinov
Department of Non-Invasive Cardiology
Ruzinovska 6
Bratislava
SR-82606
Slovakia

Additional identifiers

EudraCT number

2006-006246-34

ClinicalTrials.gov number

Protocol/serial number

CL3-16257-068

Study information

Scientific title

Acronym

Study hypothesis

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.

As of 23/07/2012 the anticipated end date for this trial has been updated from 30/01/2012 to 31/01/2013
As of 03/03/2011 the anticipated end date for this trial has been updated from 15/11/2009 to 30/01/2012.

Ethics approval

First Latvian Ethics Committee, 14/09/2007

Study design

Randomised, double-blind, parallel-group ,international, multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Angina pectoris

Intervention

All participants will be given either:
a. 5 mg/day amlodipine (oral) for 6 weeks or
b. 30 mg/day nifedipine GastroIntestinal Therapeutic System (GITS) (oral) for 6 weeks

In addition, they will be given either ivabradine or placebo according to random allocation:
Group 1: 5 mg twice a day (bid) ivabradine for 2 weeks then uptitration to 7.5 mg bid (except if HR< 60 bpm and/or symptomatic bradycardia) for 4 weeks
Group 2: Placebo daily for 6 weeks

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Response to treatment, evaluated over a 6-week treatment period, will be 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), performed according to a modified Bruce protocol at the trough of ivabradine activity (i.e. 12 ± 1 hours post-dosing) and 24 ± 2 hours after amlodipine or nifedipine administration on centrally read values.

ETT will be performed at SEL, W0, and W6 (trough and peak of ivabradine activity) visits and the following parameters will be measured:
1. Total Exercise Duration (TED, sec)*
2. Time to onset of 1 mm ST segment depression (TST 1 mm, sec)*
3. Time to onset of angina pain (TAO, sec)**
4. Time to Limiting Angina (TLA, sec)**
5. Heart Rate at rest and at peak of exercise (HR, bpm)*
6. Rate Pressure Product at rest and at peak of exercise (RPP, bpm x mmHg)*
* Evaluated by Core Reading Centre
** Evaluated by investigator

Secondary outcome measures

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 rest and at peak exercise):
1.1. At the trough of ivabradine activity (i.e. 12 ± 1 hours post-dosing) and 24 ± 2 hours after nifedipine or amlodipine administration
1.2. At the peak of ivabradine activity (i.e. 3 ± 1 hours post-dosing) and 3 ± 1 hours after nifedipine or amlodipine administration
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

Overall trial start date

15/12/2007

Overall trial end date

31/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Stable angina pectoris
2. Patients already treated with amlodipine or nifedipine
3. Sinus rhythm: heart rate 60 beats per minute

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

1,240

Participant exclusion criteria

Heart rate <60 beats per minute

Recruitment start date

15/12/2007

Recruitment end date

31/01/2013

Locations

Countries of recruitment

Argentina, Armenia, Brazil, Bulgaria, Chile, Estonia, Hungary, India, Korea, South, Lithuania, Mexico, Moldova, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, Tunisia, Ukraine

Trial participating centre

Faculty Hospital Ruzinov
Bratislava
SR-82606
Slovakia

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes