Efficacy and Safety Evaluation of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia on Lipid Modifying Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02107898
First received: April 4, 2014
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable daily statin therapy with or without other lipid modifying therapy in comparison with placebo after 24 weeks of treatment in heterozygous familial hypercholesterolemia or high cardiovascular risk patients with hypercholesterolemia.

Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
  • To evaluate the effect of alirocumab on other lipid parameters.
  • To evaluate the long-term effect of alirocumab in comparison with placebo on LDL-C after 52 weeks of treatment.
  • To evaluate the safety and tolerability of alirocumab.
  • To evaluate the development of anti-alirocumab antibodies.
  • To evaluate the PK of alirocumab.

Condition Intervention Phase
Hypercholesterolemia
Other: placebo
Drug: alirocumab SAR236553 (REGN727)
Drug: pravastatin
Drug: simvastatin
Drug: fluvastatin
Drug: atorvastatin
Drug: pitavastatin
Drug: rosuvastatin
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, Multicenter Study to Evaluate the Efficacy and Safety of Alirocumab in Heterozygous Familial Hypercholesterolemia or High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The percent change in calculated LDL-C [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percent change in calculated LDL-C [ Time Frame: From baseline to Week 12 ] [ Designated as safety issue: No ]
  • The percent change in calculated LDL-C [ Time Frame: From baseline to Week 52 ] [ Designated as safety issue: No ]
  • The proportion of patients reaching LDL-C goal [ Time Frame: At Week 24 ] [ Designated as safety issue: No ]
  • The percent change in other lipid parameters [ Time Frame: From baseline to Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab
Injection through subcutaneous administration With stable daily statin With or without other lipid modifying therapy - Type: Experimental
Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Drug: pravastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: simvastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: fluvastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: atorvastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: pitavastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: rosuvastatin
Pharmaceutical form:tablet Route of administration: oral
Placebo Comparator: Placebo
Injection through subcutaneous administration With stable daily statin With or without other lipid modifying therapy
Other: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
Drug: pravastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: simvastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: fluvastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: atorvastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: pitavastatin
Pharmaceutical form:tablet Route of administration: oral
Drug: rosuvastatin
Pharmaceutical form:tablet Route of administration: oral

Detailed Description:

Approximately 63 weeks (i.e., 14 months) (screening: 3 weeks, double-blind treatment period: 52 weeks, and follow-up period: 8 weeks).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Patients with heterozygous familial hypercholesterolemia or non-familial hypercholesterolemia who are not adequately controlled with a stable daily dose of statin with or without other lipid modifying therapy, at stable dose prior to the screening visit (Week -3).

Exclusion criteria:

  1. LDL-C <100 mg/dL (<2.59 mmol/L) at the screening visit (Week -3) in patients with heterozygous familial hypercholesterolemia or in patients with non-familial hypercholesterolemia who have a history of documented coronary heart disease as described in Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
  2. LDL-C <120 mg/dL (<3.10 mmol/L) at the screening visit (Week -3) in patients with non-familial hypercholesterolemia who have a history of documented diseases or other risk factors as categorized in primary prevention category III as described in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
  3. Not on a stable daily dose of lipid modifying therapy (including statin) within 4 weeks prior to the screening visit (Week -3) or between screening and randomization visits.
  4. Age <20 years at the screening visit (Week -3).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a 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: NCT02107898

Locations
Japan
Investigational Site Number 392029
Adachi-Ku, Japan
Investigational Site Number 392016
Adachi-Ku, Japan
Investigational Site Number 392024
Aki-Gun, Japan
Investigational Site Number 392013
Chuo-Ku, Japan
Investigational Site Number 392012
Chuo-Ku, Japan
Investigational Site Number 392032
Fukui-Shi, Japan
Investigational Site Number 392004
Hakusan-Shi, Japan
Investigational Site Number 392028
Kaga-Shi, Japan
Investigational Site Number 392002
Kanazawa-Shi, Japan
Investigational Site Number 392005
Kanazawa-Shi, Japan
Investigational Site Number 392023
Kawanishi-Shi, Japan
Investigational Site Number 392009
Kisarazu-Shi, Japan
Investigational Site Number 392026
Kitakyushu-Shi, Japan
Investigational Site Number 392003
Komatsu-Shi, Japan
Investigational Site Number 392011
Kuki-Shi, Japan
Investigational Site Number 392017
Matsumoto-Shi, Japan
Investigational Site Number 392007
Mito-Shi, Japan
Investigational Site Number 392006
Moriya-Shi, Japan
Investigational Site Number 392018
Nagoya-Shi, Japan
Investigational Site Number 392014
Oota-Ku, Japan
Investigational Site Number 392020
Osaka-Shi, Japan
Investigational Site Number 392019
Osaka-Shi, Japan
Investigational Site Number 392022
Osaka-Shi, Japan
Investigational Site Number 392030
Osaka-Shi, Japan
Investigational Site Number 392027
Oyabe-Shi, Japan
Investigational Site Number 392010
Saitama-Shi, Japan
Investigational Site Number 392015
Shinjuku-Ku, Japan
Investigational Site Number 392031
Shizuoka-Shi, Japan
Investigational Site Number 392021
Suita-Shi, Japan
Investigational Site Number 392025
Takamatsu-Shi, Japan
Investigational Site Number 392008
Tsuchiura-Shi, Japan
Investigational Site Number 392001
Yamagata-Shi, Japan
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02107898     History of Changes
Other Study ID Numbers: EFC13672, U1111-1115-7486
Study First Received: April 4, 2014
Last Updated: September 5, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias
Atorvastatin
Rosuvastatin
Pitavastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014