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Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01926782
First received: August 19, 2013
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to determine if the study drug (alirocumab)administered every 4 weeks, given by injection under the skin is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants' current cholesterol-lowering medication.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percent change in calculated LDL-C with concomitant statins [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in calculated LDL-C from baseline to week 24 for alirocumab q4w in comparison with placebo after 24 weeks of treatment in patients with hypercholesterolemia at moderate, high, or very high CVD risk who received concomitant statin therapy.

  • Percent change in calculated LDL-C without concomitant statins [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in calculated LDL-C from baseline to week 24 for alirocumab q4w in comparison with placebo after 24 weeks of treatment in patients with hypercholesterolemia who did not receive concomitant statin therapy.


Secondary Outcome Measures:
  • Percent change in calculated LDL-C [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in calculated LDL-C from baseline to week 12

  • Percent change in ApoB [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in apolipoprotein (Apo) B from baseline to week 24

  • Percent change in non- HDL-C [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in non-high-density lipoprotein cholesterol (non- HDL-C) from baseline to week 24

  • Percent change in total cholesterol [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in total cholesterol from baseline to week 24

  • Percent change in ApoB [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in ApoB from baseline to week 12

  • Percent change in non-HDL-C [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in non-HDL-C from baseline to week 12

  • Percent change in total cholesterol [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in total cholesterol from baseline to week 12

  • Proportion of patients reaching LDL-C goal [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
    The proportion of patients reaching LDL-C goal at week 24

  • Proportion of patients reaching LDL-C <70 mg/dL [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
    The proportion of patients reaching LDL-C <70 mg/dL at week 24

  • Proportion of patients reaching LDL-C <100 mg/dL [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
    The proportion of patients reaching LDL-C <100 mg/dL at week 24

  • Percent change in Lp(a) [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in Lp(a) [lipoprotein (a)] from baseline to week 24

  • Percent change in HDL-C [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in HDL-C from baseline to week 24

  • Percent change in Lp(a) [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in Lp(a) from baseline to week 12

  • Percent change in HDL-C [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in HDL-C from baseline to week 12

  • Percent change in fasting TG [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in fasting TG (triglycerides) from baseline to week 24

  • Percent change in ApoA-1 [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    The percent change in ApoA-1 from baseline to week 24

  • Percent change in fasting TG [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in fasting TG from baseline to week 12

  • Percent change in ApoA-1 [ Time Frame: baseline to week 12 ] [ Designated as safety issue: No ]
    The percent change in ApoA-1 from baseline to week 12


Enrollment: 803
Study Start Date: October 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
dosing regimen 1
Drug: Alirocumab
Experimental: Group 2
dosing regimen 2
Drug: Alirocumab
Placebo Comparator: Group 3
Placebo matching alirocumab
Drug: placebo

  Eligibility

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

Inclusion Criteria:

  1. Men and women > age 18 or legal age of majority with elevated LDL-C
  2. Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk
  3. Willing and able to comply with clinic visits and study-related procedures
  4. Provide signed informed consent

Exclusion Criteria:

  1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease
  2. Known history of positive test for human immunodeficiency virus (HIV)
  3. Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or patients with short life expectancy.
  4. Patients considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator feels would restrict or limit the patient's participation for the duration of the study.
  5. Certain laboratory findings obtained during the screening period

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

  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: NCT01926782

  Show 104 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01926782     History of Changes
Other Study ID Numbers: R727-CL-1308
Study First Received: August 19, 2013
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Bulgaria: Bulgarian Drug Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Israel: Ministry of Health
Norway: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on November 25, 2014