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Evaluation of Alirocumab SAR236553 (REGN727) When Co-administered With Atorvastatin in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL

This study has been completed.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01288469
First received: February 1, 2011
Last updated: June 27, 2013
Last verified: December 2012

February 1, 2011
June 27, 2013
January 2011
July 2011   (final data collection date for primary outcome measure)
Percent change in calculated low-density lipoprotein cholesterol (LDL-C) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01288469 on ClinicalTrials.gov Archive Site
  • Absolute change in calculated low-density lipoprotein cholesterol (LDL-C) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an low-density lipoprotein cholesterol (LDL-C) level lower than 100mg/dL (2.59 mmol/L) [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Proportion of patients achieving an low-density lipoprotein cholesterol (LDL-C) level lower than 70mg/dL (1.81 mmol/L) [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Percent change in Total Cholesterol (TC) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
  • Percent change in Triglycerides (TG) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
  • Percent change in High-density lipoprotein cholesterol (HDL-C) [ Time Frame: from baseline to Week 8 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Alirocumab SAR236553 (REGN727) When Co-administered With Atorvastatin in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL
A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose/Dose Regimen, Multicenter Study Evaluating the Efficacy and Safety of SAR236553 When Co-administered With 80 mg of Atorvastatin Over 8 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥2.59 mmol/L) on Atorvastatin 10 mg

Primary Objective:

o To evaluate the effect of alirocumab SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in patients with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg.

Secondary Objectives:

  • To evaluate the effects of alirocumab SAR236553 (REGN727) on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.
  • To evaluate the efficacy of alirocumab SAR236553 (REGN727) when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg.
  • To evaluate the safety and tolerability of alirocumab SAR236553 (REGN727) when co-administered with 2 different doses of atorvastatin.
  • 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:

  • For patients receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening, the study participation will be approximately 17 weeks including a screening period of 1 week, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.
  • For patients receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive patients the study participation will be approximately 23 weeks with a screening period of 7 weeks (including a run-in period of 6 weeks), a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: alirocumab SAR236553 (REGN727)

    Pharmaceutical form:solution for injection

    Route of administration: subcutaneous

  • Drug: alirocumab SAR236553 (REGN727) matching placebo

    Pharmaceutical form:solution for injection

    Route of administration: subcutaneous

  • Drug: atorvastatin

    Pharmaceutical form:tablet

    Route of administration: oral

  • Experimental: alirocumab SAR236553 (REGN727) + atorvastatin 80mg

    alirocumab SAR236553 (REGN727) at dose 1 regimen, will be administered in one subcutaneous (SC) injection of 1 mL in the abdomen every two weeks. Atorvastatin will be administered once daily at a stable dose of :

    • 10 mg as background therapy during the run-in period,
    • 80 mg (two over-encapsulated tablets of 40 mg) during the double-blind treatment period.
    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Drug: atorvastatin
  • Placebo Comparator: alirocumab SAR236553(REGN727)matching placebo+atorvastatin80mg

    alirocumab SAR236553 (REGN727) matching placebo, at dose 1 regimen, will be administered in one subcutaneous (SC) injection of 1 mL in the abdomen every two weeks. Atorvastatin will be administered once daily at a stable dose of :

    • 10 mg as background therapy during the run-in period,
    • 80 mg (two over-encapsulated tablets of 40 mg) during the double-blind treatment period.
    Interventions:
    • Drug: alirocumab SAR236553 (REGN727) matching placebo
    • Drug: atorvastatin
  • Experimental: alirocumab SAR236553 (REGN727) + atorvastatin 10 mg

    alirocumab SAR236553 (REGN727) at dose 1 regimen, will be administered in one subcutaneous (SC) injection of 1 mL in the abdomen every two weeks. Atorvastatin will be administered once daily at a stable dose of :

    • 10 mg as background therapy during the run-in period,
    • 10 mg (1 over-encapsulated atorvastatin 10 mg tablet + 1 matching placebo tablet) during the double-blind treatment period.
    Interventions:
    • Drug: alirocumab SAR236553 (REGN727)
    • Drug: atorvastatin
Roth EM, McKenney JM, Hanotin C, Asset G, Stein EA. Atorvastatin with or without an antibody to PCSK9 in primary hypercholesterolemia. N Engl J Med. 2012 Nov 15;367(20):1891-900. doi: 10.1056/NEJMoa1201832. Epub 2012 Oct 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92
September 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion criteria:

  • Patients (patients receiving a lipid-lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening period, or drug naive patients) with primary hypercholesterolemia likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the run-in period on atorvastatin therapy (Week -1).

OR

  • Patients with primary hypercholesterolemia treated with stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening period and likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit (Week -1).

Exclusion criteria:

  • LDL-C < 100 mg/dL (< 2.59 mmol/L) at Week -1 (V1):
  • After the run-in period on atorvastatin 10 mg for patients receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to the screening period, or drug naive patients.

OR

  • At the first visit for patients who are being treated with atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening visit Week -1.
  • Patients not previously instructed on a cholesterol-lowering diet.
  • Patients with type 1 diabetes.
  • Patients with type 2 diabetes treated with insulin.
  • Patients with type 2 diabetes and with an HbA1c ≥ 8.5% at Week -7 or Week -1 (considered poorly controlled).
  • Laboratory findings measured before randomization:

    • Triglycerides (TG) > 350 mg/dL (> 3.95 mmol/L) at Week -7 or Week -1.
    • Positive serum or urine pregnancy test in females of childbearing potential.
  • Pregnant or breast-feeding women.
  • Women of childbearing potential with no effective contraceptive method.

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

Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01288469
DFI11566, U1111-1117-9994
Yes
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
December 2012

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