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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	17 February 2014
Main ID:	EUCTR2009-011360-10-HU
Date of registration:	04/09/2009
Prospective Registration:	Yes
Primary sponsor:	Institut de Recherches Internationales Servier
Public title:	Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. - SIGNIFY
Scientific title:	Effects of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. - SIGNIFY
Date of first enrolment:	14/09/2009
Target sample size:	11330
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011360-10
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
Phase:

Countries of recruitment
Austria	Belgium	Bulgaria	Czech Republic	Denmark	Estonia	Finland	France
Germany	Greece	Hungary	Ireland	Italy	Latvia	Lithuania	Netherlands
Norway	Portugal	Slovenia	Spain	Sweden	United Kingdom

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
- Aged 55 years or older,
- Male or female,
- Patients with stable coronary artery disease without clinical heart failure,
- Sinus rhythm and resting heart rate equal or higher than 70 bpm.
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:
- Unstable cardiovascular condition,
- Contra-indications to the administration of ivabradine or current treatment with marketed ivabradine.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Coronary artery disease
MedDRA version: 12.0 Level: LLT Classification code 10011078 Term:

Intervention(s)

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: S16257-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

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: S16257-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7.5-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: S16257
Product Code: S16257
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Ivabradine
CAS Number: 155974-00-8
Current Sponsor code: S16257-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: Efficacy and safety.

Main Objective: To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.

Primary end point(s): Composite endpoint made of cardiovascular mortality or non fatal myocardial infarction.

Secondary Outcome(s)

Secondary ID(s)

2009-011360-10-ES

CL3-16257-083

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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