Main
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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:
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EUCTR |
Last refreshed on:
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10 February 2014 |
Main ID: |
EUCTR2009-011360-10-EE |
Date of registration:
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07/10/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effects of ivabradine in patients with stable coronary artery disease without heart failure
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Scientific title:
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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:
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27/10/2009 |
Target sample size:
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16850 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-011360-10 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Argentina
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Armenia
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Australia
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Austria
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Belgium
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Bulgaria
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Canada
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China
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Croatia
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Czech Republic
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Denmark
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Estonia
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Finland
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France
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Georgia
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Germany
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Greece
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Hong Kong
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Hungary
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India
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Ireland
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Italy
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Kazakhstan
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Korea, Democratic People's Republic of
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Latvia
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Lithuania
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Macedonia, the former Yugoslav Republic of
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Malaysia
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Mexico
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Netherlands
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New Zealand
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Norway
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Peru
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Philippines
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Poland
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Portugal
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Romania
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Russian Federation
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Serbia
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Singapore
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Slovakia
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Slovenia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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Thailand
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Turkey
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Ukraine
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United Kingdom
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Uruguay
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Vietnam
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Contacts
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Name:
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Clincial Studies Department
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Address:
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50, rue Carnot
92284
SURESNES cedex
France |
Telephone:
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+33155 72 43 66 |
Email:
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clinicaltrials@servier.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Name:
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Clincial Studies Department
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Address:
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50, rue Carnot
92284
SURESNES cedex
France |
Telephone:
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+33155 72 43 66 |
Email:
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clinicaltrials@servier.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Key inclusion & exclusion criteria
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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 8900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7950
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
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Coronary artery disease MedDRA version: 14.1
Level: PT
Classification code 10011078
Term: Coronary artery disease
System Organ Class: 10007541 - Cardiac disorders
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Intervention(s)
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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
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Composite endpoint measured up to 48 months
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Primary end point(s): Composite endpoint made of cardiovascular mortality or non fatal myocardial infarction.
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Main Objective: To evaluate the effect of ivabradine on cardiovascular events in patients with coronary artery disease.
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Secondary Objective: Efficacy and safety.
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Secondary Outcome(s)
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Secondary end point(s): efficacy and safety endpoints
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Timepoint(s) of evaluation of this end point: efficacy and safety endpoints measured up to 48 months
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Secondary ID(s)
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ISRCTN61576291
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2009-011360-10-ES
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CL3-16257-083
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Source(s) of Monetary Support
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ADIR
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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