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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01663402
First received: August 8, 2012
Last updated: March 2, 2017
Last verified: March 2017
  Purpose

Primary 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.

Secondary Objectives:

  • 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.

Condition Intervention Phase
Acute Coronary Syndrome
Drug: alirocumab
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to Month 64 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Up to Month 64 ]
  • Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ]

Estimated Enrollment: 18600
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab

Injection through subcutaneous (SC) administration

Alirocumab is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Drug: alirocumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous

Other Names:
  • SAR236553
  • REGN727
Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration
Drug: Placebo

Pharmaceutical form: solution for injection

Route of administration: subcutaneous


Detailed Description:

The maximum study duration will be 64 months, including up to a 4-month run-in period, 60 months randomized treatment period.

Number of patients aged from 18 to 64 years and >= 65 years old are based on the number of randomized patients (18600 patients).

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.

Exclusion criteria:

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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01663402

  Show 1388 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01663402     History of Changes
Other Study ID Numbers: EFC11570
2011-005698-21 ( EudraCT Number )
U1111-1127-4323 ( Other Identifier: UTN )
Study First Received: August 8, 2012
Last Updated: March 2, 2017

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 23, 2017