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Open Label Study of Long Term Safety Evaluation of Alirocumab (ODYSSEY OLE)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Alirocumab
Lipid-Modifying Therapy (LMT)
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717).

Exclusion criteria:

Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 840321
  • Investigational Site Number 840341
  • Investigational Site Number 840334
  • Investigational Site Number 840319
  • Investigational Site Number 840336
  • Investigational Site Number 840339
  • Investigational Site Number 840337
  • Investigational Site Number 840306
  • Investigational Site Number 840328
  • Investigational Site Number 840344
  • Investigational Site Number 840353
  • Investigational Site Number 840318
  • Investigational Site Number 840327
  • Investigational Site Number 840309
  • Investigational Site Number 840351
  • Investigational Site Number 840315
  • Investigational Site Number 840305
  • Investigational Site Number 840333
  • Investigational Site Number 840329
  • Investigational Site Number 840345
  • Investigational Site Number 840338
  • Investigational Site Number 840322
  • Investigational Site Number 840346
  • Investigational Site Number 840317
  • Investigational Site Number 840349
  • Investigational Site Number 840314
  • Investigational Site Number 840316
  • Investigational Site Number 840324
  • Investigational Site Number 840303
  • Investigational Site Number 840320
  • Investigational Site Number 840348
  • Investigational Site Number 840340
  • Investigational Site Number 840302
  • Investigational Site Number 840330
  • Investigational Site Number 840352
  • Investigational Site Number 840308
  • Investigational Site Number 840342
  • Investigational Site Number 840304
  • Investigational Site Number 840311
  • Investigational Site Number 840312
  • Investigational Site Number 840301
  • Investigational Site Number 840343
  • Investigational Site Number 840354
  • Investigational Site Number 840350
  • Investigational Site Number 032302
  • Investigational Site Number 032301
  • Investigational Site Number 040302
  • Investigational Site Number 040303
  • Investigational Site Number 040301
  • Investigational Site Number 056301
  • Investigational Site Number 100302
  • Investigational Site Number 100301
  • Investigational Site Number 124303
  • Investigational Site Number 124302
  • Investigational Site Number 124301
  • Investigational Site Number 124306
  • Investigational Site Number 124305
  • Investigational Site Number 124304
  • Investigational Site Number 203307
  • Investigational Site Number 203305
  • Investigational Site Number 203301
  • Investigational Site Number 203306
  • Investigational Site Number 203303
  • Investigational Site Number 203309
  • Investigational Site Number 203304
  • Investigational Site Number 203302
  • Investigational Site Number 208301
  • Investigational Site Number 208306
  • Investigational Site Number 208302
  • Investigational Site Number 208303
  • Investigational Site Number 208304
  • Investigational Site Number 246302
  • Investigational Site Number 246301
  • Investigational Site Number 246304
  • Investigational Site Number 250303
  • Investigational Site Number 250304
  • Investigational Site Number 250302
  • Investigational Site Number 250301
  • Investigational Site Number 250305
  • Investigational Site Number 250306
  • Investigational Site Number 276302
  • Investigational Site Number 276305
  • Investigational Site Number 276306
  • Investigational Site Number 276301
  • Investigational Site Number 276307
  • Investigational Site Number 348301
  • Investigational Site Number 376302
  • Investigational Site Number 376304
  • Investigational Site Number 376303
  • Investigational Site Number 376301
  • Investigational Site Number 380302
  • Investigational Site Number 380304
  • Investigational Site Number 380303
  • Investigational Site Number 380301
  • Investigational Site Number 484301
  • Investigational Site Number 528317
  • Investigational Site Number 528301
  • Investigational Site Number 528320
  • Investigational Site Number 528309
  • Investigational Site Number 528313
  • Investigational Site Number 528319
  • Investigational Site Number 528322
  • Investigational Site Number 528325
  • Investigational Site Number 528302
  • Investigational Site Number 528324
  • Investigational Site Number 528318
  • Investigational Site Number 528305
  • Investigational Site Number 528311
  • Investigational Site Number 528312
  • Investigational Site Number 528315
  • Investigational Site Number 528326
  • Investigational Site Number 528303
  • Investigational Site Number 528323
  • Investigational Site Number 528321
  • Investigational Site Number 528316
  • Investigational Site Number 578301
  • Investigational Site Number 578305
  • Investigational Site Number 578304
  • Investigational Site Number 620302
  • Investigational Site Number 620301
  • Investigational Site Number 642302
  • Investigational Site Number 643304
  • Investigational Site Number 643303
  • Investigational Site Number 643302
  • Investigational Site Number 643308
  • Investigational Site Number 643305
  • Investigational Site Number 643310
  • Investigational Site Number 643301
  • Investigational Site Number 643306
  • Investigational Site Number 643312
  • Investigational Site Number 710311
  • Investigational Site Number 710307
  • Investigational Site Number 710306
  • Investigational Site Number 710302
  • Investigational Site Number 710309
  • Investigational Site Number 710312
  • Investigational Site Number 710304
  • Investigational Site Number 710313
  • Investigational Site Number 710303
  • Investigational Site Number 710305
  • Investigational Site Number 710314
  • Investigational Site Number 710315
  • Investigational Site Number 710310
  • Investigational Site Number 710308
  • Investigational Site Number 724303
  • Investigational Site Number 724308
  • Investigational Site Number 724306
  • Investigational Site Number 724312
  • Investigational Site Number 724307
  • Investigational Site Number 724301
  • Investigational Site Number 724309
  • Investigational Site Number 724305
  • Investigational Site Number 724311
  • Investigational Site Number 724314
  • Investigational Site Number 724315
  • Investigational Site Number 724310
  • Investigational Site Number 724313
  • Investigational Site Number 724304
  • Investigational Site Number 724302
  • Investigational Site Number 752302
  • Investigational Site Number 752301
  • Investigational Site Number 752304
  • Investigational Site Number 826318
  • Investigational Site Number 826304
  • Investigational Site Number 826301
  • Investigational Site Number 826311
  • Investigational Site Number 826310
  • Investigational Site Number 826302
  • Investigational Site Number 826317
  • Investigational Site Number 826306
  • Investigational Site Number 826312
  • Investigational Site Number 826303
  • Investigational Site Number 826305
  • Investigational Site Number 826313
  • Investigational Site Number 826309
  • Investigational Site Number 826315
  • Investigational Site Number 826316

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alirocumab 75 or 150 mg Q2W

Arm Description

Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced Adverse Events (AEs)
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.

Secondary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.

Full Information

First Posted
September 16, 2013
Last Updated
June 29, 2018
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01954394
Brief Title
Open Label Study of Long Term Safety Evaluation of Alirocumab
Acronym
ODYSSEY OLE
Official Title
Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732 and LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients With Heterozygous Familial Hypercholesterolemia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
December 17, 2013 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: To assess the long-term safety of alirocumab (SAR236553/REGN727) when added to lipid-lowering therapy in participants with heterozygous familial hypercholesterolemia (heFH) who had completed EFC12492 (NCT01623115), R727-CL-1112 (NCT01709500), EFC12732 (NCT01617655) and LTS11717 (NCT01507831). Secondary Objectives: To evaluate the long-term efficacy of alirocumab on lipid parameters. To evaluate the long-term immunogenicity of alirocumab.
Detailed Description
The maximum study duration will be 176 weeks per participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
986 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alirocumab 75 or 150 mg Q2W
Arm Type
Experimental
Arm Description
Alirocumab 75 mg or 150 mg every 2 weeks (Q2W) added to stable lipid-modifying therapy (LMT) for up to 168 additional weeks (or until the product was commercially available) in participants who completed the parent studies EFC12492, R727-CL-1112, EFC12732 and LTS11717.
Intervention Type
Drug
Intervention Name(s)
Alirocumab
Other Intervention Name(s)
SAR236553, REGN727, Praluent
Intervention Description
Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
Intervention Type
Drug
Intervention Name(s)
Lipid-Modifying Therapy (LMT)
Intervention Description
Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Adverse Events (AEs)
Description
Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of alirocumab in this study up to the last dose of alirocumab received in this study +70 days). Clinically significant lab and vital sign abnormalities were to be reported as AEs.
Time Frame
Up to 10 weeks after last study drug administration (maximum of 176 weeks)
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Calculated LDL-C at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) Over Time
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) Over Time
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percentage of Participants With Calculated LDL-C <70 mg/dL (1.81mmol/L) and/or >=50% Reduction in Calculated LDL-C From Baseline (if Calculated LDL-C >=70 mg/dL [1.81mmol/L]) Over Time
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percent Change From Baseline in Total-cholesterol at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percent Change From Baseline in High Density Lipoprotein Cholesterol (HDL-C) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percent Change From Baseline in Fasting Triglycerides (TGs) at Weeks 8, 24, 48, 72, 96, 120, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 8, 24, 48, 72, 96, 120, 144, and 168
Title
Percent Change From Baseline in Lipoprotein (a) at Weeks 48, 96, 144 and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 48, 96, 144, and 168
Title
Percent Change From Baseline in Apolipoprotein-B (Apo-B) at Weeks 48, 96, 144, and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 48, 96, 144, and 168
Title
Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Weeks 48, 96, 144, and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 48, 96, 144, and 168
Title
Absolute Change From Baseline in Apo B/Apo A-1 Ratio at Weeks 48, 96, 144, and 168
Description
Baseline here corresponds to the baseline in the parent study (EFC12492, R727-CL-1112, EFC12732 or LTS11717). Post-baseline on-treatment data was obtained from Week 8 onwards up to Week 168 in this study.
Time Frame
Parent Baseline, Weeks 48, 96, 144, and 168

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants with heFH who had completed one of the four parent studies (EFC12492, R727-CL-1112, EFC12732 and LTS11717). Exclusion criteria: Significant protocol deviation in the parent study; Any permanent treatment discontinuation from the parent study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840321
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Investigational Site Number 840341
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Investigational Site Number 840334
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Investigational Site Number 840319
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Investigational Site Number 840336
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigational Site Number 840339
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Investigational Site Number 840337
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Investigational Site Number 840306
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Investigational Site Number 840328
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Investigational Site Number 840344
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Investigational Site Number 840353
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Investigational Site Number 840318
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308-4311
Country
United States
Facility Name
Investigational Site Number 840327
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Investigational Site Number 840309
City
Miami
State/Province
Florida
ZIP/Postal Code
33174
Country
United States
Facility Name
Investigational Site Number 840351
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Investigational Site Number 840315
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Investigational Site Number 840305
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
Investigational Site Number 840333
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Investigational Site Number 840329
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Investigational Site Number 840345
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
Facility Name
Investigational Site Number 840338
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Investigational Site Number 840322
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Investigational Site Number 840346
City
Framingham
State/Province
Massachusetts
ZIP/Postal Code
01702
Country
United States
Facility Name
Investigational Site Number 840317
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Investigational Site Number 840349
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Investigational Site Number 840314
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Investigational Site Number 840316
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Investigational Site Number 840324
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Investigational Site Number 840303
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Investigational Site Number 840320
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigational Site Number 840348
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Investigational Site Number 840340
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Investigational Site Number 840302
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Investigational Site Number 840330
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Investigational Site Number 840352
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Facility Name
Investigational Site Number 840308
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Investigational Site Number 840342
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18503
Country
United States
Facility Name
Investigational Site Number 840304
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Investigational Site Number 840311
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Investigational Site Number 840312
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Name
Investigational Site Number 840301
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Investigational Site Number 840343
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Investigational Site Number 840354
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Investigational Site Number 840350
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Investigational Site Number 032302
City
Caba
ZIP/Postal Code
C1119ACN
Country
Argentina
Facility Name
Investigational Site Number 032301
City
Coronel Suarez
ZIP/Postal Code
B7540GHD
Country
Argentina
Facility Name
Investigational Site Number 040302
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Investigational Site Number 040303
City
Sankt Stefan
ZIP/Postal Code
8511
Country
Austria
Facility Name
Investigational Site Number 040301
City
Wien
ZIP/Postal Code
1130
Country
Austria
Facility Name
Investigational Site Number 056301
City
Natoye
ZIP/Postal Code
5360
Country
Belgium
Facility Name
Investigational Site Number 100302
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Investigational Site Number 100301
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Investigational Site Number 124303
City
Chicoutimi
ZIP/Postal Code
G7H 7K9
Country
Canada
Facility Name
Investigational Site Number 124302
City
Montreal
ZIP/Postal Code
H1W 2R7
Country
Canada
Facility Name
Investigational Site Number 124301
City
Quebec
ZIP/Postal Code
G1V 4W2
Country
Canada
Facility Name
Investigational Site Number 124306
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number 124305
City
Toronto
ZIP/Postal Code
M5C 2T2
Country
Canada
Facility Name
Investigational Site Number 124304
City
Victoria
ZIP/Postal Code
V8T 5G4
Country
Canada
Facility Name
Investigational Site Number 203307
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Investigational Site Number 203305
City
Praha 2
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Investigational Site Number 203301
City
Praha 4
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Investigational Site Number 203306
City
Praha 5 - Motol
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Investigational Site Number 203303
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Investigational Site Number 203309
City
Trutnov
ZIP/Postal Code
54121
Country
Czechia
Facility Name
Investigational Site Number 203304
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Facility Name
Investigational Site Number 203302
City
Zlin
ZIP/Postal Code
76275
Country
Czechia
Facility Name
Investigational Site Number 208301
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Investigational Site Number 208306
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Investigational Site Number 208302
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Investigational Site Number 208303
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Investigational Site Number 208304
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Facility Name
Investigational Site Number 246302
City
Joensuu
ZIP/Postal Code
80100
Country
Finland
Facility Name
Investigational Site Number 246301
City
Kokkola
ZIP/Postal Code
67100
Country
Finland
Facility Name
Investigational Site Number 246304
City
Vantaa
ZIP/Postal Code
01600
Country
Finland
Facility Name
Investigational Site Number 250303
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Investigational Site Number 250304
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Investigational Site Number 250302
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Investigational Site Number 250301
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Investigational Site Number 250305
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Investigational Site Number 250306
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Investigational Site Number 276302
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Investigational Site Number 276305
City
Frankfurt A.M.
ZIP/Postal Code
60596
Country
Germany
Facility Name
Investigational Site Number 276306
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Investigational Site Number 276301
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Investigational Site Number 276307
City
Witten
ZIP/Postal Code
58455
Country
Germany
Facility Name
Investigational Site Number 348301
City
Baja
ZIP/Postal Code
6500
Country
Hungary
Facility Name
Investigational Site Number 376302
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Investigational Site Number 376304
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigational Site Number 376303
City
Safed
ZIP/Postal Code
13110
Country
Israel
Facility Name
Investigational Site Number 376301
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Investigational Site Number 380302
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Investigational Site Number 380304
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Investigational Site Number 380303
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Investigational Site Number 380301
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Investigational Site Number 484301
City
Mexico
ZIP/Postal Code
03300
Country
Mexico
Facility Name
Investigational Site Number 528317
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Investigational Site Number 528301
City
Amsterdam-Zuidoost
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Investigational Site Number 528320
City
Apeldoorn
ZIP/Postal Code
7314 ET
Country
Netherlands
Facility Name
Investigational Site Number 528309
City
Delfzijl
ZIP/Postal Code
9934 JD
Country
Netherlands
Facility Name
Investigational Site Number 528313
City
Eindhoven
ZIP/Postal Code
5616GB
Country
Netherlands
Facility Name
Investigational Site Number 528319
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Investigational Site Number 528322
City
Goes
ZIP/Postal Code
4462 RA
Country
Netherlands
Facility Name
Investigational Site Number 528325
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Investigational Site Number 528302
City
Groningen
ZIP/Postal Code
9728 NT
Country
Netherlands
Facility Name
Investigational Site Number 528324
City
Hoogeveen
ZIP/Postal Code
7909 AA
Country
Netherlands
Facility Name
Investigational Site Number 528318
City
Hoorn
ZIP/Postal Code
1624 NP
Country
Netherlands
Facility Name
Investigational Site Number 528305
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Investigational Site Number 528311
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Investigational Site Number 528312
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Investigational Site Number 528315
City
Rotterdam
ZIP/Postal Code
3021 HC
Country
Netherlands
Facility Name
Investigational Site Number 528326
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Investigational Site Number 528303
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
Investigational Site Number 528323
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Investigational Site Number 528321
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Investigational Site Number 528316
City
Waalwijk
ZIP/Postal Code
5141 BM
Country
Netherlands
Facility Name
Investigational Site Number 578301
City
Bodo
ZIP/Postal Code
8092
Country
Norway
Facility Name
Investigational Site Number 578305
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Investigational Site Number 578304
City
Oslo
Country
Norway
Facility Name
Investigational Site Number 620302
City
Funchal
ZIP/Postal Code
9004-514
Country
Portugal
Facility Name
Investigational Site Number 620301
City
Lisboa
ZIP/Postal Code
1169-024
Country
Portugal
Facility Name
Investigational Site Number 642302
City
Timisoara
ZIP/Postal Code
300358
Country
Romania
Facility Name
Investigational Site Number 643304
City
Arkhangelsk
ZIP/Postal Code
163000
Country
Russian Federation
Facility Name
Investigational Site Number 643303
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Investigational Site Number 643302
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
Facility Name
Investigational Site Number 643308
City
Moscow
ZIP/Postal Code
121552
Country
Russian Federation
Facility Name
Investigational Site Number 643305
City
Moscow
ZIP/Postal Code
129301
Country
Russian Federation
Facility Name
Investigational Site Number 643310
City
Novosibirsk
ZIP/Postal Code
630089
Country
Russian Federation
Facility Name
Investigational Site Number 643301
City
St Petersbourg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Investigational Site Number 643306
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Investigational Site Number 643312
City
St.Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Investigational Site Number 710311
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Investigational Site Number 710307
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 710306
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Investigational Site Number 710302
City
Cape Town
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Investigational Site Number 710309
City
Centurion
ZIP/Postal Code
0158
Country
South Africa
Facility Name
Investigational Site Number 710312
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Investigational Site Number 710304
City
Parow
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Investigational Site Number 710313
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Investigational Site Number 710303
City
Pretoria
ZIP/Postal Code
0084
Country
South Africa
Facility Name
Investigational Site Number 710305
City
Pretoria
ZIP/Postal Code
0157
Country
South Africa
Facility Name
Investigational Site Number 710314
City
Pretoria
ZIP/Postal Code
0184
Country
South Africa
Facility Name
Investigational Site Number 710315
City
Roodepoort
ZIP/Postal Code
1724
Country
South Africa
Facility Name
Investigational Site Number 710310
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Investigational Site Number 710308
City
Witbank
Country
South Africa
Facility Name
Investigational Site Number 724303
City
A Coruna
ZIP/Postal Code
15001
Country
Spain
Facility Name
Investigational Site Number 724308
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Investigational Site Number 724306
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Investigational Site Number 724312
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Investigational Site Number 724307
City
Hospitalet De Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Investigational Site Number 724301
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Investigational Site Number 724309
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Investigational Site Number 724305
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724311
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Investigational Site Number 724314
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 724315
City
Quart De Poblet
ZIP/Postal Code
46930
Country
Spain
Facility Name
Investigational Site Number 724310
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Investigational Site Number 724313
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Investigational Site Number 724304
City
Tarragona
ZIP/Postal Code
43204
Country
Spain
Facility Name
Investigational Site Number 724302
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Investigational Site Number 752302
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Investigational Site Number 752301
City
Stockholm
ZIP/Postal Code
111 35
Country
Sweden
Facility Name
Investigational Site Number 752304
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Investigational Site Number 826318
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Investigational Site Number 826304
City
Brighton
ZIP/Postal Code
BN1 9PH
Country
United Kingdom
Facility Name
Investigational Site Number 826301
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Investigational Site Number 826311
City
Cambridge
ZIP/Postal Code
CB2 OQQ
Country
United Kingdom
Facility Name
Investigational Site Number 826310
City
Cardiff
ZIP/Postal Code
CF14 5GJ
Country
United Kingdom
Facility Name
Investigational Site Number 826302
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Investigational Site Number 826317
City
Liverpool
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Investigational Site Number 826306
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Investigational Site Number 826312
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Investigational Site Number 826303
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Investigational Site Number 826305
City
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Investigational Site Number 826313
City
Newcastle Upon Tyne
ZIP/Postal Code
NEI 4LP
Country
United Kingdom
Facility Name
Investigational Site Number 826309
City
Reading
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Investigational Site Number 826315
City
West Bromwich
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Investigational Site Number 826316
City
West Bromwich
ZIP/Postal Code
B71 4HJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30591415
Citation
Dufour R, Hovingh GK, Guyton JR, Langslet G, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Individualized low-density lipoprotein cholesterol reduction with alirocumab titration strategy in heterozygous familial hypercholesterolemia: Results from an open-label extension of the ODYSSEY LONG TERM trial. J Clin Lipidol. 2019 Jan-Feb;13(1):138-147. doi: 10.1016/j.jacl.2018.11.007. Epub 2018 Nov 30.
Results Reference
derived
PubMed Identifier
30293878
Citation
Farnier M, Hovingh GK, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Guyton JR. Long-term safety and efficacy of alirocumab in patients with heterozygous familial hypercholesterolemia: An open-label extension of the ODYSSEY program. Atherosclerosis. 2018 Nov;278:307-314. doi: 10.1016/j.atherosclerosis.2018.08.036. Epub 2018 Sep 1.
Results Reference
derived
PubMed Identifier
30287210
Citation
Hovingh GK, Guyton JR, Langslet G, Dufour R, Baccara-Dinet MT, Din-Bell C, Manvelian G, Farnier M. Alirocumab dosing patterns during 40 months of open-label treatment in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2018 Nov-Dec;12(6):1463-1470. doi: 10.1016/j.jacl.2018.08.011. Epub 2018 Aug 30.
Results Reference
derived

Learn more about this trial

Open Label Study of Long Term Safety Evaluation of Alirocumab

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