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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 22, 2015
Last verified: January 2015

March 14, 2013
January 22, 2015
March 2013
January 2014   (final data collection date for primary outcome measure)
Percent change in calculated low-density lipoprotein cholesterol (LDL-C) at Week 12 [ Time Frame: From baseline (randomization) to Week 12 ] [ 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 ]
Complete list of historical versions of study NCT01812707 on ClinicalTrials.gov Archive Site
  • Absolute change in calculated low-density lipoprotein cholesterol (LDL-C) at Week 12 [ Time Frame: From baseline (randomization) to Week 12 ] [ Designated as safety issue: No ]
  • Percent and absolute changes in other lipid parameters at Week 12 [ Time Frame: From baseline (randomization) to Week 12 ] [ Designated as safety issue: No ]
  • 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 ]
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

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 effect of alirocumab 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 on other lipid levels after 12 weeks of treatment in comparison with placebo.
  • To evaluate the safety and tolerability of alirocumab.
  • To evaluate the development of anti-alirocumab antibodies.
  • To evaluate the pharmacokinetics of alirocumab.

The duration of study participation will depend on the status of the patient at screening: 21 to 27 weeks including a screening/run-in 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

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous injection (1 mL) in the abdomen

    Other Names:
    • SAR236553
    • RGEN727
  • Drug: Placebo (for alirocumab)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous injection (1 mL) in the abdomen

  • Drug: Atorvastatin

    Pharmaceutical form: tablet

    Route of administration: oral administration in the evening

  • Experimental: Alirocumab dose 1
    Alirocumab dose 1 every 2 weeks through subcutaneous injection (SC) + atorvastatin stable dose orally once daily (background therapy)
    Interventions:
    • Drug: Alirocumab
    • Drug: Atorvastatin
  • Experimental: Alirocumab dose 2
    Alirocumab dose 2 every 2 weeks through subcutaneous injection (SC) + atorvastatin stable dose orally once daily (background therapy)
    Interventions:
    • Drug: Alirocumab
    • Drug: Atorvastatin
  • Experimental: Alirocumab dose 3
    Alirocumab dose 3 every 2 weeks through subcutaneous injection (SC) + atorvastatin stable dose orally once daily (background therapy)
    Interventions:
    • Drug: Alirocumab
    • Drug: Atorvastatin
  • Placebo Comparator: Placebo
    Placebo (for alirocumab) every 2 weeks through subcutaneous injection (SC) + atorvastatin stable dose orally once daily (background therapy)
    Interventions:
    • Drug: Placebo (for alirocumab)
    • 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 if they are likely to have LDL-C ≥100 mg/dL (≥2.59 mmol/L) after a 6-week run-in treatment period on atorvastatin therapy.

Exclusion criteria:

  1. LDL-C <100 mg/dL (<2.59 mmol/L)

    • at screening visit for patients who are being treated with stable dose of atorvastatin 5-20 mg for at least 6 weeks prior to screening OR
    • at the end of the 6-week run-in period on atorvastatin 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.
  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 2015

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