Study of the Efficacy and Safety of REGN727 (SAR236553) in Combination With Other Lipid-modifying Treatments (LMT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01730040
First received: November 9, 2012
Last updated: October 7, 2013
Last verified: October 2013

November 9, 2012
October 7, 2013
October 2012
March 2014   (final data collection date for primary outcome measure)
Percent change in calculated LDL-C to wk 24 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]
Percent change in calculated LDL-C (low-density lipoprotein cholesterol) from baseline to week 24.
Same as current
Complete list of historical versions of study NCT01730040 on ClinicalTrials.gov Archive Site
  • Percent change in calculated LDL-C to wk 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    Percent change in calculated LDL-C from baseline to week 12
  • Percent change in ApoB [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in ApoB (Apolipoprotein B) at time points up to week 24.
  • Proportion of patients reaching LDL-C goal [ Time Frame: At week 24 ] [ Designated as safety issue: No ]
    Proportion of patients reaching LDL-C goal at week 24.
  • Percent change in Lp(a) [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in LP(a) [(Lipoprotein(a)] at time points up to week 24
  • Percent change in non-HDL-C [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in non HDL-C (non-high-density lipoprotein cholesterol) at time points up to week 24
  • Percent change in HDL-C [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in HDL-C at time points up to week 24
  • Percent change in total-C [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in total-C at time points up to week 24
  • Percent change in TG [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in TG (Triglycerides) at time points up to week 24
  • Percent change in ApoA-1 [ Time Frame: Baseline up to week 24 ] [ Designated as safety issue: No ]
    Percent change in ApoA-1 at time points up to week 24
Same as current
Not Provided
Not Provided
 
Study of the Efficacy and Safety of REGN727 (SAR236553) in Combination With Other Lipid-modifying Treatments (LMT)
A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin Versus Ezetimibe Added-on to Atorvastatin Versus Atorvastatin Dose Increase Versus Switch to Rosuvastatin in Patients Who Are Not Controlled on Atorvastatin

This is a randomized, double-blind, active-comparator, parallel-group study in patients at high cardiovascular risk with nonfamilial hypercholesterolemia or heterozygous familial hypercholesterolemia (heFH).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: REGN727 (SAR236553)
  • Drug: Atorvastatin
    Active comparator
  • Drug: Ezetimibe
    Active comparator
  • Drug: Rosuvastatin
    Active comparator
  • Other: Placebo
  • Experimental: Regimen 1
    REGN727 (SAR236553) added on to atorvastatin and placebo
    Interventions:
    • Drug: REGN727 (SAR236553)
    • Drug: Atorvastatin
    • Other: Placebo
  • Experimental: Regimen 2
    atorvastatin and placebo
    Interventions:
    • Drug: Atorvastatin
    • Other: Placebo
  • Experimental: Regimen 3
    atorvastatin added on to ezetimibe and placebo
    Interventions:
    • Drug: Atorvastatin
    • Drug: Ezetimibe
    • Other: Placebo
  • Experimental: Regimen 4
    REGN727 (SAR236553) added on to atorvastatin and placebo
    Interventions:
    • Drug: REGN727 (SAR236553)
    • Drug: Atorvastatin
    • Other: Placebo
  • Experimental: Regimen 5
    atorvastatin and placebo
    Interventions:
    • Drug: Atorvastatin
    • Other: Placebo
  • Experimental: Regimen 6
    rosuvastatin and placebo
    Interventions:
    • Drug: Rosuvastatin
    • Other: Placebo
  • Experimental: Regimen 7
    atorvastatin added on to ezetimibe
    Interventions:
    • Drug: Atorvastatin
    • Drug: Ezetimibe
    • Other: 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
347
May 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with screening (visit 1) LDL-C greater than or equal to 70 mg/dL with documented CVD, not adequately controlled with a daily dose of atorvastatin. OR
  2. Patients with screening (visit 1) LDL-C greater than or equal to 100 mg/dL at high risk for CVD who are not adequately controlled with a daily dose of atorvastatin.

Exclusion Criteria:

  1. LDL-C greater than 250 mg/dL
  2. LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
  3. LDL-C less than 100 mg/dL at the screening visit in patients without history of documented CHD or non-CHD CVD, but with other risk factors
  4. TG greater than 400 mg/dL
  5. Homozygous FH (clinically or previous genotyping)
  6. Currently taking a statin that is not atorvastatin
  7. Currently taking Ezetimibe (EZE)
  8. Not on a stable dose of allowable lipid modifying treatments (LMT)

(The inclusion/ exclusion criteria provided above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial).

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Italy,   Mexico,   Spain,   United Kingdom
 
NCT01730040
R727-CL-1110
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
October 2013

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