Study of REGN727 (SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy) (Odyssey FH II)

This study is currently recruiting participants.

Verified January 2013 by Regeneron Pharmaceuticals

Sponsor:

Collaborator:

Sanofi

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01709500

First received: October 8, 2012

Last updated: January 23, 2013

Last verified: January 2013

History of Changes

Purpose

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study REGN727 (SAR236553) in patients with Heterozygous Familial Hypercholesterolemia (heFH) who are not adequately controlled with their Lipid-Modifying Therapy (LMT).

Condition	Intervention	Phase
Heterozygous Familial Hypercholesterolemia	Drug: LMT (atorvastatin, simvastatin, or rosuvastatin) Drug: REGN727 (SAR236553) Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of REGN727/SAR236553 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: Chanarin-Dorfman syndrome cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:

Percent change in LDL-C to week 24 [ Time Frame: Baseline to Wk 24 ] [ Designated as safety issue: No ]
The percent change in calculated LDL-C (low-density lipoprotein cholesterol) from baseline to week 24

Secondary Outcome Measures:

Percent change in LDL-C to weeks 12 and 52. [ Time Frame: Baseline to Wks 12 and 52 ] [ Designated as safety issue: No ]
The percent change in calculated LDL-C from baseline to weeks 12 and 52.
Percent change in ApoB, non-HDL-C, total-C, HDL-C, Lp(a), TG, and Apo A-1 [ Time Frame: Baseline to Wks 12 and 24 ] [ Designated as safety issue: No ]
The percent change in ApoB, non-HDL-C, total-C, HDL-C, Lp(a), TG, and Apo A-1 from baseline to weeks 12 and 24.
Proportion of patients reaching LDL-C goal [ Time Frame: At Wk 24 ] [ Designated as safety issue: No ]
The proportion of patients reaching LDL-C goal at week 24
Proportion of patients reaching LDL-C <70 mg/dL (1.81 mmol/L) [ Time Frame: At Wk 24 ] [ Designated as safety issue: No ]
The proportion of patients reaching LDL-C <70 mg/dL (1.81 mmol/L) at week 24

Estimated Enrollment:	250
Study Start Date:	December 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Regimen 1 LMT (atorvastatin, simvastatin, or rosuvastatin) and REGN727 (SAR236553)	Drug: LMT (atorvastatin, simvastatin, or rosuvastatin) Drug: REGN727 (SAR236553)
Active Comparator: Regimen 2 LMT (atorvastatin, simvastatin, or rosuvastatin) and Placebo	Drug: LMT (atorvastatin, simvastatin, or rosuvastatin) 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 heFH who are not adequately controlled with their LMT

Exclusion Criteria:

Age less than 18 years or legal age of adulthood, whichever is greater
LDL-C less than 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
LDL-C less than 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
Fasting serum triglycerides greater than 400 mg/dL (4.52 mmol/L)
Known history of homozygous familial hypercholesterolemia

(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: NCT01709500

Contacts

Contact: Clinical Trials Administrator

clinicaltrials@regeneron.com

Locations

Czech Republic
	Recruiting
Hradec Kralove, Czech Republic
	Recruiting
Praha 2, Czech Republic
	Recruiting
Praha 5, Czech Republic
	Recruiting
Praha 8, Czech Republic
	Recruiting
Trutnov, Czech Republic
	Recruiting
Vyskov, Czech Republic
Netherlands
	Recruiting
Alkmaar, Netherlands
	Recruiting
Amsterdam, Netherlands
	Recruiting
Apeldoorn, Netherlands
	Recruiting
Enschede, Netherlands
	Recruiting
Goes, Netherlands
	Recruiting
Groningen, Netherlands
	Recruiting
Hoogeveen, Netherlands
	Recruiting
Hoom, Netherlands
	Recruiting
Rotterdam, Netherlands
	Recruiting
Sittard- Geleen, Netherlands
	Recruiting
Utrecht, Netherlands
	Recruiting
Venlo, Netherlands
	Recruiting
Waalwijk, Netherlands
Norway
	Recruiting
Oslo, Norway
United Kingdom
	Recruiting
Cardiff, United Kingdom
	Recruiting
London, United Kingdom
	Recruiting
Manchester, United Kingdom
	Recruiting
Middlesex, United Kingdom
	Recruiting
Newcastle upon Tyne, United Kingdom
	Recruiting
West Bromwich, United Kingdom

Sponsors and Collaborators

Regeneron Pharmaceuticals

Sanofi

Investigators

Study Director:

Dan Gipe, MD

Regeneron Pharmaceuticals

More Information

No publications provided

Responsible Party:	Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01709500 History of Changes
Other Study ID Numbers:	R727-CL-1112
Study First Received:	October 8, 2012
Last Updated:	January 23, 2013
Health Authority:	Czech Republic: State Institute for Drug Control Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Hyperlipoproteinemia Type II
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Simvastatin

Atorvastatin
Rosuvastatin
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 16, 2013

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