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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Primary Purpose

Hypercholesterolaemia

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 Hypercholesterolaemia

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
LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3).
Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period.
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 Q2W

Alirocumab 150 mg Q2W

Arm Description

Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.

Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Calculated LDL-C at Week 24 - 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 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 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 a multiple imputation approach model 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 a 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 a 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

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 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.

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 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 including available post-baseline on-treatment data from Week 4 to Week 52 i.e. up to 21 days after last injection.

Full Information

NCT ID

NCT01617655

First Posted

June 8, 2012

Last Updated

September 27, 2016

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01617655

Brief Title

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

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 and LDL-C Higher or Equal to 160mg/dL With Their Lipid-Modifying Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

January 2015 (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

Hypercholesterolaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Q2W

Arm Type

Placebo Comparator

Arm Description

Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.

Arm Title

Alirocumab 150 mg Q2W

Arm Type

Experimental

Arm Description

Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.

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 - 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 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 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 a 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

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 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 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

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 model 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 LDL-C < 160 mg/dL (< 4.14 mmol/L) at the screening visit (Week-3). Fasting serum triglycerides > 400 mg/dL (> 4.52 mmol/L) during the screening period. 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 840742

City

Bell Gardens

State/Province

California

ZIP/Postal Code

90201

Country

United States

Facility Name

Investigational Site Number 840703

City

Newport Beach

State/Province

California

ZIP/Postal Code

92660

Country

United States

Facility Name

Investigational Site Number 840712

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Investigational Site Number 840743

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Facility Name

Investigational Site Number 840734

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20037

Country

United States

Facility Name

Investigational Site Number 840738

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Investigational Site Number 840710

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Investigational Site Number 840701

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Investigational Site Number 840702

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Investigational Site Number 840714

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Investigational Site Number 840705

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 840709

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 840713

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Investigational Site Number 840736

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Investigational Site Number 124704

City

Quebec

ZIP/Postal Code

G1V 4M6

Country

Canada

Facility Name

Investigational Site Number 124703

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 528713

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

Facility Name

Investigational Site Number 528701

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Investigational Site Number 528704

City

Groningen

ZIP/Postal Code

9728 NT

Country

Netherlands

Facility Name

Investigational Site Number 528716

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Investigational Site Number 528709

City

Utrecht

ZIP/Postal Code

3582 KE

Country

Netherlands

Facility Name

Investigational Site Number 643706

City

Arkhangelsk

ZIP/Postal Code

163000

Country

Russian Federation

Facility Name

Investigational Site Number 643705

City

Kazan

ZIP/Postal Code

420012

Country

Russian Federation

Facility Name

Investigational Site Number 643703

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

Investigational Site Number 643711

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

Investigational Site Number 643708

City

Moscow

ZIP/Postal Code

129301

Country

Russian Federation

Facility Name

Investigational Site Number 643702

City

Saint Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Investigational Site Number 643710

City

St-Petersburg

ZIP/Postal Code

193079

Country

Russian Federation

Facility Name

Investigational Site Number 643709

City

St-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

Investigational Site Number 643707

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Investigational Site Number 710701

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Investigational Site Number 710704

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Investigational Site Number 710706

City

Cap Town

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Investigational Site Number 710702

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Investigational Site Number 710703

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

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

27618825

Citation

Ginsberg HN, Rader DJ, Raal FJ, Guyton JR, Baccara-Dinet MT, Lorenzato C, Pordy R, Stroes E. Efficacy and Safety of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia and LDL-C of 160 mg/dl or Higher. Cardiovasc Drugs Ther. 2016 Oct;30(5):473-483. doi: 10.1007/s10557-016-6685-y.

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

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

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Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With Heterozygous Familial Hypercholesterolemia (ODYSSEY HIGH FH)

Hypercholesterolaemia

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

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