Study of Alirocumab (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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01709500
First received: October 8, 2012
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-national study alirocumab (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: alirocumab (REGN727/ SAR236553)
Drug: 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:


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


Enrollment: 249
Study Start Date: December 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1
LMT (atorvastatin, simvastatin, or rosuvastatin) and alirocumab (REGN727/ SAR236553)
Drug: LMT (atorvastatin, simvastatin, or rosuvastatin) Drug: alirocumab (REGN727/ SAR236553)
Active Comparator: Regimen 2
LMT (atorvastatin, simvastatin, or rosuvastatin) and placebo
Drug: LMT (atorvastatin, simvastatin, or rosuvastatin) Drug: 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
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: NCT01709500

Locations
Czech Republic
Hradec Kralove, Czech Republic
Praha 2, Czech Republic
Praha 5, Czech Republic
Praha 8, Czech Republic
Trutnov, Czech Republic
Vyskov, Czech Republic
Netherlands
Alkmaar, Netherlands
Amsterdam, Netherlands
Apeldoorn, Netherlands
Enschede, Netherlands
Goes, Netherlands
Groningen, Netherlands
Hoogeveen, Netherlands
Hoorn, Netherlands
Rotterdam, Netherlands
Sittard- Geleen, Netherlands
Utrecht (2 locations), Netherlands
Venlo, Netherlands
Waalwijk, Netherlands
Norway
Oslo, Norway
United Kingdom
Cardiff, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Middlesex, United Kingdom
Newcastle upon Tyne, United Kingdom
West Bromwich, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Dan Gipe, MD Regeneron Pharmaceuticals
  More Information

No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 25, 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:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Dyslipidemias
Genetic Diseases, Inborn
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism Disorders
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Atorvastatin
Rosuvastatin
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014