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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 January 2022 |
Main ID: |
EUCTR2009-011360-10-NO |
Date of registration:
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09/03/2010 |
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 clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. - SIGNIFY
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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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05/10/2012 |
Target sample size:
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11330 |
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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Bulgaria
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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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Germany
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Greece
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Hungary
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Ireland
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Italy
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Latvia
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Lithuania
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Netherlands
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Norway
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Portugal
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Slovakia
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Slovenia
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Spain
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Sweden
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United Kingdom
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Contacts
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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 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
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Health Condition(s) or Problem(s) studied
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Coronary artery disease MedDRA version: 12.0
Level: LLT
Classification code 10011078
Term:
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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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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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Primary end point(s): Composite endpoint made of cardiovascular mortality or non fatal myocardial infarction.
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Secondary ID(s)
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CL3-16257-083
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2009-011360-10-ES
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 05/10/2012
Contact:
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