Dan Gipe, MD -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 not yet open for participant recruitment. Verified October 2012 by Regeneron Pharmaceuticals Sponsor:
Regeneron Pharmaceuticals Investigators
Study Director:
Dan Gipe, MD
Collaborator:
Sanofi Information provided by (Responsible Party):
Regeneron Pharmaceuticals ClinicalTrials.gov Identifier:
NCT01709500 First received: October 8, 2012 Last updated: October 16, 2012 Last verified: October 2012 History of Changes
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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)
Phase 3
Drug: REGN727 (SAR236553) Other: Placebo
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
Study Director:
Dan Gipe, MD
Resource links provided by NLM: Genetics Home Reference related topics: ChanarinDorfman 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:
October 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
Drug: LMT (atorvastatin, simvastatin, or rosuvastatin)
LMT (atorvastatin, simvastatin, or rosuvastatin)
Drug: REGN727 (SAR236553)
and REGN727 (SAR236553) Active Comparator: Regimen 2
Drug: LMT (atorvastatin, simvastatin, or rosuvastatin)
LMT (atorvastatin, simvastatin, or rosuvastatin) and
Other: Placebo
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: 1. Age less than 18 years or legal age of adulthood, whichever is greater 2. LDL-C less than 70 mg/dL (1.81 mmol/L) and with cardiovascular disease 3. LDL-C less than 100 mg/dL (2.59 mmol/L) and without cardiovascular disease 4. Fasting serum triglycerides greater than 400 mg/dL (4.52 mmol/L)
5. 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 Not yet recruiting TBD, Czech Republic
Netherlands Not yet recruiting TBD, Netherlands
Norway Not yet recruiting TBD, Norway
United Kingdom Not yet recruiting TBD, 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
Other Study ID Numbers:
R727-CL-1112
History of Changes
Study First Received:
October 8, 2012
Last Updated:
October 16, 2012
Health Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Norway: Norwegian Medicines Agency Czech Republic: State Institute for Drug Control United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms: Hypercholesterolemia
Atorvastatin
Hyperlipoproteinemia Type II
Rosuvastatin
Hyperlipidemias
Hypolipidemic Agents
Dyslipidemias
Antimetabolites
Lipid Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Metabolic Diseases
Pharmacologic Actions
Lipid Metabolism, Inborn Errors
Lipid Regulating Agents
Metabolism, Inborn Errors
Therapeutic Uses
Genetic Diseases, Inborn
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hyperlipoproteinemias
Anticholesteremic Agents
Simvastatin
Enzyme Inhibitors
ClinicalTrials.gov processed this record on October 29, 2012