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
  Purpose

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).


Condition Intervention Phase
Hypercholesterolemia
Drug: REGN727 (SAR236553)
Drug: Atorvastatin
Drug: Ezetimibe
Drug: Rosuvastatin
Other: 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 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 347
Study Start Date: October 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1
REGN727 (SAR236553) added on to atorvastatin and placebo
Drug: REGN727 (SAR236553) Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 2
atorvastatin and placebo
Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 3
atorvastatin added on to ezetimibe and placebo
Drug: Atorvastatin
Active comparator
Drug: Ezetimibe
Active comparator
Other: Placebo
Experimental: Regimen 4
REGN727 (SAR236553) added on to atorvastatin and placebo
Drug: REGN727 (SAR236553) Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 5
atorvastatin and placebo
Drug: Atorvastatin
Active comparator
Other: Placebo
Experimental: Regimen 6
rosuvastatin and placebo
Drug: Rosuvastatin
Active comparator
Other: Placebo
Experimental: Regimen 7
atorvastatin added on to ezetimibe
Drug: Atorvastatin
Active comparator
Drug: Ezetimibe
Active comparator
Other: Placebo

  Eligibility

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

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).

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01730040

  Show 97 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: NCT01730040     History of Changes
Other Study ID Numbers: R727-CL-1110
Study First Received: November 9, 2012
Last Updated: October 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Rosuvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014