Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01507831
First received: January 6, 2012
Last updated: November 25, 2014
Last verified: November 2014
  Purpose

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9).

Primary Objective of the study:

To evaluate the long-term safety and tolerability of alirocumab in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT).

Secondary Objectives:

  • To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo.
  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points.
  • To evaluate the effects of alirocumab on other lipid parameters.

Condition Intervention Phase
Hypercholesterolemia
Drug: Placebo
Drug: Alirocumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) [ Time Frame: Up to 86 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent change in calculated LDL-C at Week 24 [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
    From a mixed-effect model including all LDL-C values collected up to Week 52

  • Percent change in calculated LDL-C at Week 12 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]
  • Percent change in other lipid parameters at Week 12, 24 and 52 [ Time Frame: From baseline up to Week 52 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percent change in calculated LDL-C at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]
    From a mixed-effect model including all LDL-C values collected up to Week 78

  • Percent change in other lipid parameters at Week 78 [ Time Frame: From baseline up to Week 78 ] [ Designated as safety issue: No ]

Enrollment: 2341
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab

Injection through subcutaneous (SC) administration.

Background statin therapy or other lipid modifying therapy will be administered according to site investigator discretion as background therapy.

Drug: Alirocumab

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Other Names:
  • SAR236553
  • REGN727
Placebo Comparator: Placebo

Injection through subcutaneous (SC) administration.

Background statin therapy or other lipid modifying therapy will be administered according to site investigator discretion as background therapy.

Drug: Placebo

Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous


Detailed Description:

The maximum study duration will be 89 weeks per patient, including a 78-week randomized treatment period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Either A or B below and who are not adequately controlled with their lipid-modifying therapy:

A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

OR

B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria:

  • Age < 18 years
  • LDL-C <70 mg/dL (< 1.81 mmol/L)
  • Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

The above information is not intended to contain all considerations relevant to a patient&apos;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: NCT01507831

  Show 320 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01507831     History of Changes
Other Study ID Numbers: LTS11717, 2011-002806-59, U1111-1121-3928
Study First Received: January 6, 2012
Last Updated: November 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 25, 2014