Back to results

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Placebo (for alirocumab)

Alirocumab

Lipid-Modifying Therapy (LMT)

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 hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2)

Exclusion criteria:

Age <18 or legal age of adulthood, whichever was greater
Participants without established CHD or CHD risk equivalent
LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease
LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented cardiovascular disease
Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization
Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

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

Arm Description

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.

Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when 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 were obtained 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 (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 Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis

Adjusted percentages at Week 24 were obtained from 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 Participants Reaching 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 were obtained from multiple imputation approach followed by robust regression 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.

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 be 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 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

Adjusted means and standard errors at Week 12 from multiple imputation approach followed by a 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 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

NCT01644175

First Posted

July 16, 2012

Last Updated

October 7, 2015

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01644175

Brief Title

Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 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 proprotein convertase subtilisin/kexin type 9 (PCSK9). Primary Objective of the study: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular (CV) risk participants with hypercholesterolemia Secondary Objectives: To evaluate the effect of alirocumab in comparison with placebo on LDL-C at other time points To evaluate the effect of alirocumab on other lipid parameters To evaluate the safety and tolerability of alirocumab

Detailed Description

The maximum study duration was 62 weeks per participant, including a 2-week screening period, 52-week randomized treatment period, and 8-week follow-up period.

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

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

316 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Q2W

Arm Type

Placebo Comparator

Arm Description

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.

Arm Title

Alirocumab

Arm Type

Experimental

Arm Description

Alirocumab 75 mg Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Intervention Type

Drug

Intervention Name(s)

Placebo (for alirocumab)

Intervention Description

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).

Intervention Type

Drug

Intervention Name(s)

Alirocumab

Other Intervention Name(s)

SAR236553, REGN727

Intervention Description

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable 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 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 (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

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

Description

Time Frame

Up to Week 52

Title

Percentage of Participants Reaching 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 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who were not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks to 6 weeks prior to screening (Week -2) Exclusion criteria: Age <18 or legal age of adulthood, whichever was greater Participants without established CHD or CHD risk equivalent LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented cardiovascular disease LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented cardiovascular disease Not on a stable dose of LMT (including statin) for at least 4 weeks and/or fenofibrate for at least 6 weeks, as applicable, prior to the screening visit (Week -2) and from screening to randomization Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L) 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 840857

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Investigational Site Number 840891

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36693

Country

United States

Facility Name

Investigational Site Number 840876

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36109

Country

United States

Facility Name

Investigational Site Number 840865

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Investigational Site Number 840826

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

Investigational Site Number 840870

City

Burbank

State/Province

California

ZIP/Postal Code

91505

Country

United States

Facility Name

Investigational Site Number 840851

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

Investigational Site Number 840845

City

Los Gatos

State/Province

California

ZIP/Postal Code

95032

Country

United States

Facility Name

Investigational Site Number 840844

City

Sacramento

State/Province

California

ZIP/Postal Code

95823

Country

United States

Facility Name

Investigational Site Number 840801

City

San Jose

State/Province

California

ZIP/Postal Code

95116

Country

United States

Facility Name

Investigational Site Number 840886

City

Tarzana

State/Province

California

ZIP/Postal Code

91356

Country

United States

Facility Name

Investigational Site Number 840862

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Investigational Site Number 840893

City

Vista

State/Province

California

ZIP/Postal Code

92083

Country

United States

Facility Name

Investigational Site Number 840867

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33432

Country

United States

Facility Name

Investigational Site Number 840884

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

Investigational Site Number 840836

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33761

Country

United States

Facility Name

Investigational Site Number 840866

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Investigational Site Number 840895

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33308-4311

Country

United States

Facility Name

Investigational Site Number 840820

City

Hialeah

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840805

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

Investigational Site Number 840811

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Investigational Site Number 840881

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Investigational Site Number 840816

City

West Palm Beach

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840850

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Investigational Site Number 840840

City

Eagle

State/Province

Idaho

Country

United States

Facility Name

Investigational Site Number 840842

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Investigational Site Number 840898

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Investigational Site Number 840847

City

Morton

State/Province

Illinois

ZIP/Postal Code

61550

Country

United States

Facility Name

Investigational Site Number 840896

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Investigational Site Number 840894

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Investigational Site Number 840838

City

Mishawaka

State/Province

Indiana

ZIP/Postal Code

46545

Country

United States

Facility Name

Investigational Site Number 840823

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Investigational Site Number 840858

City

Eunice

State/Province

Louisiana

ZIP/Postal Code

70535

Country

United States

Facility Name

Investigational Site Number 840802

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Name

Investigational Site Number 840855

City

Salisbury

State/Province

Massachusetts

ZIP/Postal Code

01952

Country

United States

Facility Name

Investigational Site Number 840890

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49015

Country

United States

Facility Name

Investigational Site Number 840832

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Investigational Site Number 840839

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Investigational Site Number 840888

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Investigational Site Number 840837

City

Port Gibson

State/Province

Mississippi

ZIP/Postal Code

39150

Country

United States

Facility Name

Investigational Site Number 840814

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Investigational Site Number 840833

City

Sparks

State/Province

Nevada

Country

United States

Facility Name

Investigational Site Number 840817

City

Newington

State/Province

New Hampshire

ZIP/Postal Code

3801

Country

United States

Facility Name

Investigational Site Number 840853

City

New Windsor

State/Province

New York

ZIP/Postal Code

12553

Country

United States

Facility Name

Investigational Site Number 840822

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

Facility Name

Investigational Site Number 840824

City

Cary

State/Province

North Carolina

Country

United States

Facility Name

Investigational Site Number 840880

City

Smithfield

State/Province

North Carolina

Country

United States

Facility Name

Investigational Site Number 840502

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840852

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Investigational Site Number 840846

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

Investigational Site Number 840899

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

Investigational Site Number 840831

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43231

Country

United States

Facility Name

Investigational Site Number 840860

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Investigational Site Number 840809

City

Willoughby Hills

State/Province

Ohio

ZIP/Postal Code

44094

Country

United States

Facility Name

Investigational Site Number 840818

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Investigational Site Number 840812

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97404

Country

United States

Facility Name

Investigational Site Number 840803

City

Downington

State/Province

Pennsylvania

ZIP/Postal Code

19335

Country

United States

Facility Name

Investigational Site Number 840869

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19146

Country

United States

Facility Name

Investigational Site Number 840825

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15206

Country

United States

Facility Name

Investigational Site Number 840872

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Investigational Site Number 840885

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Investigational Site Number 840813

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Investigational Site Number 840827

City

Mt. Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Investigational Site Number 840868

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78404

Country

United States

Facility Name

Investigational Site Number 840877

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

Investigational Site Number 840841

City

Houston

State/Province

Texas

ZIP/Postal Code

77072

Country

United States

Facility Name

Investigational Site Number 840830

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78224

Country

United States

Facility Name

Investigational Site Number 840854

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Investigational Site Number 840883

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Investigational Site Number 840889

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Investigational Site Number 840878

City

Bountiful

State/Province

Utah

ZIP/Postal Code

84010

Country

United States

Facility Name

Investigational Site Number 840819

City

Orem

State/Province

Utah

ZIP/Postal Code

84058

Country

United States

Facility Name

Investigational Site Number 840863

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84102

Country

United States

Facility Name

Investigational Site Number 840804

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

Investigational Site Number 840882

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Investigational Site Number 840810

City

Weber City

State/Province

Virginia

ZIP/Postal Code

24290

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25240705

Citation

Colhoun HM, Robinson JG, Farnier M, Cariou B, Blom D, Kereiakes DJ, Lorenzato C, Pordy R, Chaudhari U. Efficacy and safety of alirocumab, a fully human PCSK9 monoclonal antibody, in high cardiovascular risk patients with poorly controlled hypercholesterolemia on maximally tolerated doses of statins: rationale and design of the ODYSSEY COMBO I and II trials. BMC Cardiovasc Disord. 2014 Sep 20;14:121. doi: 10.1186/1471-2261-14-121.

Results Reference

background

PubMed Identifier

26027630

Citation

Kereiakes DJ, Robinson JG, Cannon CP, Lorenzato C, Pordy R, Chaudhari U, Colhoun HM. Efficacy and safety of the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab among high cardiovascular risk patients on maximally tolerated statin therapy: The ODYSSEY COMBO I study. Am Heart J. 2015 Jun;169(6):906-915.e13. doi: 10.1016/j.ahj.2015.03.004. Epub 2015 Mar 13.

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

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 High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO I)

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 High Cardiovascular Risk and Hypercholesterolemia (ODYSSEY COMBO 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