Back to results

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Alirocumab

Placebo (for alirocumab)

Lipid Modifying Therapy (LMT)

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring PCSK9

Eligibility Criteria

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

Inclusion criteria:

Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy

Exclusion criteria:

Age < 18 years or legal age of adulthood, whichever is greater
LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
Known history of homozygous familial hypercholesterolemia

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Alirocumab 75 mg/Up to 150 mg Q2W

Arm Description

Placebo for alirocumab every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.

Alirocumab 75 mg Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were used in the model (ITT analysis).

Secondary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection) (on-treatment analysis).

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Percent Change From Baseline in Apo B at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in Total-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis

Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percentage of Very High Cardiovascular (CV) Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - ITT Analysis

Very high CV risk participants: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents. High CV risk participants: heFH participants without CHD or CHD risk equivalents. CHD risk equivalent: peripheral arterial disease, ischemic stroke, moderate chronic kidney disease (estimated glomerular filtration rate, 30 to <60 ml/minute/1.73 m^2 of body-surface area), or diabetes mellitus plus 2 or more additional risk factors (hypertension; ankle-brachial index of ≤0.90; microalbuminuria, macroalbuminuria, or a urinary dipstick result of >2+ protein; preproliferative or proliferative retinopathy or laser treatment for retinopathy; or a family history of premature CHD). Adjusted percentages at Week 24 were obtained from multiple imputation approach for handling of missing data. All available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment were included in the imputation model.

Percentage of Very High CV Risk Participants Achieving Calculated LDL-C < 70 mg/dL (<1.81 mmol/L) or High CV Risk Participants Achieving Calculated LDL-C < 100 mg/dL (<2.59 mmol/L) at Week 24 - On- Treatment Analysis

Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.

Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis

Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.

Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis

Adjusted means and standard errors at Week 24 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis

Adjusted means and standard errors at Week 12 from multiple imputation approach followed by robust regression model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis

Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Full Information

NCT ID

NCT01623115

First Posted

June 15, 2012

Last Updated

January 11, 2016

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01623115

Brief Title

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Acronym

ODYSSEY FH I

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Alirocumab (SAR236553/REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9). Primary Objective of the study: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. Secondary Objectives: To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points To evaluate the effects of alirocumab on other lipid parameters To evaluate the safety and tolerability of alirocumab

Detailed Description

The maximum study duration was planned to be 89 weeks per participant including participants who successfully completed the 78-week treatment period had the possibility to join an open-label extension study (LTS13463, NCT01954394) at the end of the treatment period.

6. Conditions and Keywords

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

Hypercholesterolemia

Keywords

PCSK9

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

486 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo for alirocumab every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.

Arm Title

Alirocumab 75 mg/Up to 150 mg Q2W

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Alirocumab

Other Intervention Name(s)

SAR236553, REGN727, Praluent

Intervention Description

Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).

Intervention Type

Drug

Intervention Name(s)

Placebo (for alirocumab)

Intervention Description

Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).

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

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

Description

Time Frame

From Baseline to Week 52

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

Description

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Apo B at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on-or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Total-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 52 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Description

Time Frame

Up to Week 52

Title

Description

Adjusted percentages at Week 24 from multiple imputation approach including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.

Time Frame

Up to Week 52

Title

Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

Description

Adjusted percentages at Week 24 from multiple imputation approach model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

Up to Week 52

Title

Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis

Description

Adjusted percentages at Week 24 from multiple imputation approach model including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.

Time Frame

Up to Week 52

Title

Percent Change From Baseline in Lipoprotein (a) at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis

Description

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 24 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Lipoprotein (a) at Week 12 - ITT Analysis

Description

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis

Description

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 12 from MMRM model including all available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

Time Frame

From Baseline to Week 52

Other Pre-specified Outcome Measures:

Title

Percent Change From Baseline in Calculated LDL-C at Week 52 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 52 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 52 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 52

Title

Percent Change From Baseline in Calculated LDL-C at Week 78 - ITT Analysis

Description

Adjusted LS means and standard errors at Week 78 from MMRM including all available post-baseline data from Week 4 to Week 78 regardless of status on-or off-treatment.

Time Frame

From Baseline to Week 78

Title

Percent Change From Baseline in Calculated LDL-C at Week 78 - On-Treatment Analysis

Description

Adjusted LS means and standard errors at Week 78 from MMRM model including available post-baseline on-treatment data from Week 4 to Week 78 (i.e. up to 21 days after last injection).

Time Frame

From Baseline to Week 78

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants with heterozygous familial hypercholesterolemia who were not adequately controlled with their lipid-modifying therapy Exclusion criteria: Age < 18 years or legal age of adulthood, whichever is greater LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L) Known history of homozygous familial hypercholesterolemia The above information is 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 840417

City

Bell Gardens

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

Investigational Site Number 840429

City

Long Beach

State/Province

California

ZIP/Postal Code

90801

Country

United States

Facility Name

Investigational Site Number 840419

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Investigational Site Number 840421

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

Investigational Site Number 840412

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

Investigational Site Number 840428

City

Newport Beach

State/Province

California

Country

United States

Facility Name

Investigational Site Number 840461

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Investigational Site Number 840452

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Investigational Site Number 840456

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Investigational Site Number 840418

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Investigational Site Number 840455

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Investigational Site Number 840415

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7321

Country

United States

Facility Name

Investigational Site Number 840425

City

Auburn

State/Province

Maine

ZIP/Postal Code

04210

Country

United States

Facility Name

Investigational Site Number 840411

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Investigational Site Number 840409

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Investigational Site Number 840407

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

Investigational Site Number 840408

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Investigational Site Number 840401

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Investigational Site Number 840410

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Investigational Site Number 840430

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Investigational Site Number 840424

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201-3098

Country

United States

Facility Name

Investigational Site Number 840404

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 840426

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 840406

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Investigational Site Number 840460

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Investigational Site Number 840422

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Investigational Site Number 040403

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Investigational Site Number 040402

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Investigational Site Number 040405

City

Wien

Country

Austria

Facility Name

Investigational Site Number 124404

City

Chicoutimi

ZIP/Postal Code

G7H 5H6

Country

Canada

Facility Name

Investigational Site Number 124401

City

Montreal

ZIP/Postal Code

H2W 1R7

Country

Canada

Facility Name

Investigational Site Number 124403

City

Quebec

ZIP/Postal Code

G1V 4M6

Country

Canada

Facility Name

Investigational Site Number 124406

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 124407

City

Toronto

ZIP/Postal Code

M5C 2T2

Country

Canada

Facility Name

Investigational Site Number 203401

City

Praha

ZIP/Postal Code

140 00

Country

Czech Republic

Facility Name

Investigational Site Number 203403

City

Praha

ZIP/Postal Code

180 00

Country

Czech Republic

Facility Name

Investigational Site Number 203405

City

Uherske Hradiste

Country

Czech Republic

Facility Name

Investigational Site Number 203402

City

Zlin

ZIP/Postal Code

760 00

Country

Czech Republic

Facility Name

Investigational Site Number 208401

City

Copenhagen

Country

Denmark

Facility Name

Investigational Site Number 208403

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Facility Name

Investigational Site Number 250403

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Investigational Site Number 250401

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Investigational Site Number 250402

City

Saint Herblain

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 376402

City

Holon

ZIP/Postal Code

76100

Country

Israel

Facility Name

Investigational Site Number 376405

City

Jerusalem

Country

Israel

Facility Name

Investigational Site Number 376404

City

Safed

ZIP/Postal Code

13100

Country

Israel

Facility Name

Investigational Site Number 376401

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Investigational Site Number 528406

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Investigational Site Number 528410

City

Amsterdam

Country

Netherlands

Facility Name

Investigational Site Number 528408

City

Den Helder

ZIP/Postal Code

1782 GZ

Country

Netherlands

Facility Name

Investigational Site Number 528402

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

Investigational Site Number 528411

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Investigational Site Number 528416

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Investigational Site Number 528409

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

Investigational Site Number 528412

City

Sliedrecht

Country

Netherlands

Facility Name

Investigational Site Number 578401

City

Bodø

ZIP/Postal Code

8092

Country

Norway

Facility Name

Investigational Site Number 643402

City

Arkhangelsk

ZIP/Postal Code

163000

Country

Russian Federation

Facility Name

Investigational Site Number 643407

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Investigational Site Number 643409

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Investigational Site Number 643413

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Investigational Site Number 643401

City

Moscow

ZIP/Postal Code

129301

Country

Russian Federation

Facility Name

Investigational Site Number 643412

City

Novisibirsk

Country

Russian Federation

Facility Name

Investigational Site Number 643408

City

St-Petersburg

ZIP/Postal Code

193079

Country

Russian Federation

Facility Name

Investigational Site Number 643406

City

St-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Investigational Site Number 643404

City

St-Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Investigational Site Number 643410

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Investigational Site Number 710401

City

Bloemfontein

Country

South Africa

Facility Name

Investigational Site Number 710405

City

Bloemfontein

Country

South Africa

Facility Name

Investigational Site Number 710406

City

Cap Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Investigational Site Number 710402

City

Cape Town

ZIP/Postal Code

7708

Country

South Africa

Facility Name

Investigational Site Number 710407

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Investigational Site Number 710403

City

Parow

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Investigational Site Number 710408

City

Pretoria

Country

South Africa

Facility Name

Investigational Site Number 710404

City

Rondebosch

Country

South Africa

Facility Name

Investigational Site Number 710409

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Investigational Site Number 724403

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Investigational Site Number 724408

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Investigational Site Number 724406

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Investigational Site Number 724407

City

Hospitalet De Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Investigational Site Number 724409

City

Madrid

ZIP/Postal Code

28029

Country

Spain

Facility Name

Investigational Site Number 724401

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Investigational Site Number 724405

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Investigational Site Number 724404

City

Reus

ZIP/Postal Code

43201

Country

Spain

Facility Name

Investigational Site Number 724402

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Investigational Site Number 752404

City

Goteborg

ZIP/Postal Code

41345

Country

Sweden

Facility Name

Investigational Site Number 752401

City

Stockholm

ZIP/Postal Code

111 35

Country

Sweden

Facility Name

Investigational Site Number 826402

City

London

Country

United Kingdom

Facility Name

Investigational Site Number 826403

City

London

Country

United Kingdom

Facility Name

Investigational Site Number 826408

City

London

Country

United Kingdom

Facility Name

Investigational Site Number 826409

City

London

Country

United Kingdom

Facility Name

Investigational Site Number 826405

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24842558

Citation

Kastelein JJ, Robinson JG, Farnier M, Krempf M, Langslet G, Lorenzato C, Gipe DA, Baccara-Dinet MT. Efficacy and safety of alirocumab in patients with heterozygous familial hypercholesterolemia not adequately controlled with current lipid-lowering therapy: design and rationale of the ODYSSEY FH studies. Cardiovasc Drugs Ther. 2014 Jun;28(3):281-9. doi: 10.1007/s10557-014-6523-z.

Results Reference

background

PubMed Identifier

26330422

Citation

Kastelein JJ, Ginsberg HN, Langslet G, Hovingh GK, Ceska R, Dufour R, Blom D, Civeira F, Krempf M, Lorenzato C, Zhao J, Pordy R, Baccara-Dinet MT, Gipe DA, Geiger MJ, Farnier M. ODYSSEY FH I and FH II: 78 week results with alirocumab treatment in 735 patients with heterozygous familial hypercholesterolaemia. Eur Heart J. 2015 Nov 14;36(43):2996-3003. doi: 10.1093/eurheartj/ehv370. Epub 2015 Sep 1.

Results Reference

result

PubMed Identifier

34298554

Citation

Mahmood T, Minnier J, Ito MK, Li QH, Koren A, Kam IW, Fazio S, Shapiro MD. Discordant responses of plasma low-density lipoprotein cholesterol and lipoprotein(a) to alirocumab: A pooled analysis from 10 ODYSSEY Phase 3 studies. Eur J Prev Cardiol. 2021 Jul 23;28(8):816-822. doi: 10.1177/2047487320915803. Epub 2020 Apr 10.

Results Reference

derived

PubMed Identifier

30183102

Citation

Leiter LA, Tinahones FJ, Karalis DG, Bujas-Bobanovic M, Letierce A, Mandel J, Samuel R, Jones PH. Alirocumab safety in people with and without diabetes mellitus: pooled data from 14 ODYSSEY trials. Diabet Med. 2018 Dec;35(12):1742-1751. doi: 10.1111/dme.13817. Epub 2018 Oct 9.

Results Reference

derived

PubMed Identifier

28964736

Citation

Defesche JC, Stefanutti C, Langslet G, Hopkins PN, Seiz W, Baccara-Dinet MT, Hamon SC, Banerjee P, Kastelein JJP. Efficacy of alirocumab in 1191 patients with a wide spectrum of mutations in genes causative for familial hypercholesterolemia. J Clin Lipidol. 2017 Nov-Dec;11(6):1338-1346.e7. doi: 10.1016/j.jacl.2017.08.016. Epub 2017 Sep 4. Erratum In: J Clin Lipidol. 2020 Sep - Oct;14(5):742.

Results Reference

derived

PubMed Identifier

28391886

Citation

Kastelein JJ, Hovingh GK, Langslet G, Baccara-Dinet MT, Gipe DA, Chaudhari U, Zhao J, Minini P, Farnier M. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 monoclonal antibody alirocumab vs placebo in patients with heterozygous familial hypercholesterolemia. J Clin Lipidol. 2017 Jan-Feb;11(1):195-203.e4. doi: 10.1016/j.jacl.2016.12.004. Epub 2016 Dec 28.

Results Reference

derived

PubMed Identifier

27777279

Citation

Ray KK, Ginsberg HN, Davidson MH, Pordy R, Bessac L, Minini P, Eckel RH, Cannon CP. Reductions in Atherogenic Lipids and Major Cardiovascular Events: A Pooled Analysis of 10 ODYSSEY Trials Comparing Alirocumab With Control. Circulation. 2016 Dec 13;134(24):1931-1943. doi: 10.1161/CIRCULATIONAHA.116.024604. Epub 2016 Oct 24.

Results Reference

derived

Learn more about this trial

We'll reach out to this number within 24 hrs

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy (ODYSSEY FH I)

Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial