ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab

• Register: EUCTR
• Last refreshed on: 12 March 2018
• Main ID: EUCTR2011-005698-21-GR
• Date of registration: 22/09/2014
• Prospective Registration: Yes
• Primary sponsor: sanofi-aventis Recherche & Développement
• Public title: ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
• Date of first enrolment: 16/10/2014
• Target sample size: 18000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005698-21
• 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; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States

Contacts

• Name: ?a?ß??a ?pa???ts??
• Affiliation: Sanofi Aventis

• Name: ?a?ß??a ?pa???ts??
• Affiliation: Sanofi Aventis

Key inclusion & exclusion criteria

Inclusion criteria:
o Recently (< 52 weeks) hospitalized for ACS.
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 15500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion criteria:
o Age < 40 years.
o ACS event occurring more than 52 weeks prior to randomization visit.
o LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia.


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

Health Condition(s) or Problem(s) studied

Acute coronary syndrome-
MedDRA version: 17.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Code: SAR236553 (REGN727)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: alirocumab
CAS Number: 1245916-14-6
Current Sponsor code: SAR236553 (REGN727)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Code: SAR236553 (REGN727)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: alirocumab
CAS Number: 1245916-14-6
Current Sponsor code: SAR236553 (REGN727)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.

Primary end point(s): Time from randomization to first occurrence of one of the following Clinical Events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization

Timepoint(s) of evaluation of this end point: Up to Month 64

Secondary Objective: To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality).
To evaluate the safety and tolerability of alirocumab.
To evaluate the effect of alirocumab on lipid parameters.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to Month 64

Secondary end point(s): - Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality
- Change from baseline in blood lipids and lipoprotein levels
- Number of patients with adverse events

Secondary ID(s)

2011-005698-21-GB

EFC11570

Source(s) of Monetary Support

sanofi-aventis Recherche & Développement