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 - Odyssey FH II

Regeneron Pharmaceuticals Inc.0 sites250 target enrollmentJuly 31, 2012

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Regeneron Pharmaceuticals Inc.
Enrollment: 250
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 31, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Regeneron Pharmaceuticals Inc.

Eligibility Criteria

Inclusion Criteria

•1\.Patients with heFH\* who are not adequately controlled\*\* with a maximally\-tolerated daily dose\*\*\* of statin with or without other LMT, at a stable dose prior to the screening visit (week \-2\).
•\*Diagnosis of heFH must be made either by genotyping or by clinical criteria. For those patients not genotyped, the clinical diagnosis may be based on either the Simon Broome criteria for definite FH (Appendix 1\) or the WHO/Dutch Lipid Network criteria with a score of \>8 points (Appendix 2\).
•\*\*Not adequately controlled” is defined as LDL\-C \=70 mg/dL (1\.81 mmol/L) at the screening visit (week \-2\) in patients with a history of documented CVD (Appendix 3\), or LDL\-C \=100 mg/dL (2\.59 mmol/L) at the screening visit (week \-2\) in patients without a history of documented CVD.
•\*\*\*”Maximally\-tolerated dose” is defined as (any of the following are acceptable):
•Rosuvastatin 20 mg or 40 mg daily
•Atorvastatin 40 mg or 80 mg daily
•Simvastatin 80 mg daily (if already on this dose for \>1 year – see exclusion criterion \#7\)
•Note: Patients who are not able to be on any of the above statin doses should be treated with the dose of daily atorvastatin, rosuvastatin, or simvastatin which is considered appropriate for the patient, according to the investigator's judgment. Some examples of acceptable reasons for a patient taking a lower statin dose include, but are not limited to: adverse effects on higher doses, advanced age, low body mass index, regional practices, local prescribing information, concomitant medications, co\-morbid conditions such as impaired glucose tolerance/impaired fasting glucose. The reason(s) will be documented in the case report form (CRF).
•2\.Provide signed informed consent
•Are the trial subjects under 18? no

Exclusion Criteria

•1\.Patient without diagnosis of heFH made either by genotyping or by clinical criteria
•2\.LDL\-C \<70 mg/dL (\<1\.81 mmol/L) at the screening visit (week\-2\) in patients with history of documented cardiovascular disease
•3\.LDL\-C \<100 mg/dL (\<2\.59 mmol/L) at the screening visit (week \-2\) in patients without history of documented cardiovascular disease
•4\.Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (week \-2\) and from screening to randomization
•5\.Currently taking another statin than simvastatin, atorvastatin, or rosuvastatin
•6\.Simvastatin, atorvastatin, or rosuvastatin is not taken daily or not taken at a registered dose
•7\.Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for patients on simvastatin 80 mg for more than 1 year, who are eligible)
•8\.Use of fibrates, other than fenofibrate within 6 weeks of the screening visit (week\-2\) or between screening and randomization visits
•9\.Use of nutraceutical products or over\-the\-counter therapies that may affect lipids which have not been at a stable dose/amount for at least 4 weeks prior to the screening visit (week \-2\) or between screening and randomization visits
•10\.Use of red yeast rice products within 4 weeks of the screening visit (week\-2\), or between screening and randomization visits