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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01730040
First received: November 9, 2012
Last updated: August 20, 2014
Last verified: August 2014
  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
Study Completion Date: May 2014
Primary Completion Date: April 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014