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Efficacy and Safety Evaluation of Alirocumab SAR236553 (REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01812707
First received: March 14, 2013
Last updated: January 30, 2014
Last verified: January 2014

March 14, 2013
January 30, 2014
March 2013
January 2014   (final data collection date for primary outcome measure)
Percent change in calculated low-density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01812707 on ClinicalTrials.gov Archive Site
  • Absolute change in calculated low-density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
  • Percent and absolute changes in other lipid parameters [ Time Frame: At Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Evaluation of Alirocumab SAR236553 (REGN727) in Patients With Primary Hypercholesterolemia on Stable Atorvastatin Therapy
A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Three Doses of SAR236553 (REGN727) Over 12 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥100 mg/dL (≥2.59 mmol/L) on Ongoing Stable Atorvastatin Therapy

Primary Objective:

To evaluate the effect of alirocumab SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in patients with LDL-C ≥100 mg/dL (≥2.59 mmol/L) on ongoing stable atorvastatin therapy.

Secondary Objectives:

To evaluate the effects of alirocumab SAR236553 (REGN727) on other lipid levels after 12 weeks of treatment in comparison with placebo.

To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727).

To evaluate the development of anti-alirocumab SAR236553 (REGN727) antibodies.

To evaluate the pharmacokinetics of alirocumab SAR236553 (REGN727).

The duration of study participation will depend on the status of the patient at screening: 21 to 27 weeks including a screening period of 1 to 7 weeks, a double-blind treatment period of 12 weeks, followed by an 8 week follow-up period.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: alirocumab SAR236553 (REGN727)
    Pharmaceutical form:solution for injection Route of administration: subcutaneous
  • Drug: placebo
    Pharmaceutical form:solution for injection Route of administration: subcutaneous
  • Drug: atorvastatin
    Pharmaceutical form:tablet Route of administration: oral
  • Experimental: alirocumab SAR236553 (REGN727) Dose 1

    Injection of 1 mL alirocumab SAR236553 (REGN727) Dose 1 every 2 weeks through subcutaneous administration in the abdomen.

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

    Atorvastatin will be administered once daily in the evening at a stable dose as background therapy.

    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Drug: atorvastatin
  • Experimental: alirocumab SAR236553 (REGN727) Dose 2

    Injection of 1 mL alirocumab SAR236553 (REGN727) Dose 2 every 2 weeks through subcutaneous administration in the abdomen.

    Atorvastatin will be administered once daily in the evening at a stable dose as background therapy.

    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Drug: atorvastatin
  • Experimental: alirocumab SAR236553 (REGN727) Dose 3

    Injection of 1 mL alirocumab SAR236553 (REGN727) Dose 3 every 2 weeks through subcutaneous administration in the abdomen.

    Atorvastatin will be administered once daily in the evening at a stable dose as background therapy.

    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Drug: atorvastatin
  • Placebo Comparator: Placebo

    Injection of 1 mL alirocumab SAR236553 (REGN727) matching placebo every 2 weeks through subcutaneous administration in the abdomen.

    Atorvastatin will be administered once daily in the evening at a stable dose as background therapy.

    Interventions:
    • Drug: placebo
    • Drug: atorvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion criteria :

Patients with primary hypercholesterolemia treated with atorvastatin at stable dose of 5-20 mg for at least 6 weeks prior to screening and likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) at the screening visit.

OR Patients with primary hypercholesterolemia who are receiving a lipid-lowering treatment other than atorvastatin, or who are not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening and who are likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after the run-in period on atorvastatin therapy.

Exclusion criteria:

  1. LDL-C <100 mg/dL (<2.59 mmol/L) at Week -1 (V1): At the first visit for patients who are being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening period.

    OR After the run-in period on atorvastatin (5-20 mg) for patients receiving a lipid lowering treatment other than atorvastatin, or not at stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening period.

  2. Patients with type 1 diabetes
  3. Patients with type 2 diabetes treated with insulin, or without, and considered poorly controlled at screening.

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

Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01812707
DFI12361, U1111-1134-4749
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2014

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