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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

January 6, 2012
November 25, 2014
January 2012
November 2014   (final data collection date for primary outcome measure)
Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) [ Time Frame: Up to 86 weeks ] [ Designated as safety issue: Yes ]
Assessment of safety parameters (adverse events [including adjudicated cardiovascular events, laboratory data, vital signs, and ECG]) [ Time Frame: Up to 20 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01507831 on ClinicalTrials.gov Archive Site
  • 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 ]
Percent change in calculated low density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to week 12 ] [ Designated as safety issue: No ]
  • 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 ]
Not Provided
 
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)
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

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Placebo

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

  • Drug: Alirocumab

    Pharmaceutical form: Solution for injection

    Route of administration: Subcutaneous

    Other Names:
    • SAR236553
    • REGN727
  • 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.

    Intervention: Drug: Alirocumab
  • 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.

    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2341
November 2014
November 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Bulgaria,   Canada,   Chile,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Romania,   Russian Federation,   South Africa,   Spain,   Sweden,   Ukraine,   United Kingdom
 
NCT01507831
LTS11717, 2011-002806-59, U1111-1121-3928
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP