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

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:

MedlinePlus related topics: Cholesterol

Drug Information available for: Atorvastatin calcium Rosuvastatin calcium Ezetimibe Rosuvastatin

U.S. FDA Resources

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

Estimated Enrollment:	350
Study Start Date:	October 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	December 2013 (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:

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
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:

LDL-C greater than 250 mg/dL
LDL-C less than 70 mg/dL at the screening visit in patients with history of documented CVD
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
TG greater than 400 mg/dL
Homozygous FH (clinically or previous genotyping)
Currently taking a statin that is not atorvastatin
Currently taking Ezetimibe (EZE)
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

Contacts

Contact: Clinical Trials Administrator

clinicaltrials@regeneron.com

Locations

United States, Alabama
	Recruiting
Mobile, Alabama, United States
United States, Kansas
	Recruiting
Newton, Kansas, United States
United States, Kentucky
	Recruiting
Lexington, Kentucky, United States
	Recruiting
Louisville, Kentucky, United States
United States, Maine
	Recruiting
Auburn, Maine, United States
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States
United States, Ohio
	Recruiting
Cleveland, Ohio, United States
United States, Texas
	Recruiting
Dallas, Texas, United States
Australia
	Recruiting
TBD, Australia
Brazil
	Not yet recruiting
TBD, Brazil
Canada
	Recruiting
Montreal, Canada
France
	Not yet recruiting
TBD, France
Germany
	Not yet recruiting
TBD, Germany
Italy
	Not yet recruiting
TBD, Italy
Mexico
	Not yet recruiting
TBD, Mexico
Spain
	Recruiting
TBD, Spain
United Kingdom
	Not yet recruiting
TBD, United Kingdom

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:	March 18, 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 June 17, 2013