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Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

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:

Either A or B below and who were not adequately controlled with their lipid-modifying therapy:

A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents

B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents.

Exclusion criteria:

Age < 18 years
LDL-C <70 mg/dL (< 1.81 mmol/L)
Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L)

The above information was 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

Arm Description

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.

Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced Adverse Events (AEs)

Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the 'treatment-emergent period' (the time from the first dose of study drug up to the last dose of study drug +70 days).

Secondary 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).

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 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 Measured LDL-C at Week 24 - ITT Analysis

Measured LDL-C values via beta quantification method. Adjusted LS means and standard errors at Week 24 from MMRM model including available post-baseline data from Week 4 to Week 52 regardless of status on- or off-treatment.

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 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).

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.

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

Very high CV risk: Heterozygous Familial Hypercholesterolemia (heFH) participants with coronary heart disease (CHD) or CHD risk equivalents or non- Familial Hypercholesterolemia (FH). High CV risk: 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 family history of premature CHD). 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 imputation model.

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

Adjusted percentages at Week 24 were 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).

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 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 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 Apo A1 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 A1 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

NCT01507831

First Posted

January 6, 2012

Last Updated

November 18, 2015

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01507831

Brief Title

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

Official Title

Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 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 long-term safety and tolerability of alirocumab in high cardiovascular risk participants with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT). Secondary Objectives: To evaluate the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo. 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.

Detailed Description

The maximum study duration was to be 89 weeks per participant, including a 3-week screening period, a 78-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

2341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (for alirocumab) every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 78 weeks.

Arm Title

Alirocumab

Arm Type

Experimental

Arm Description

Alirocumab 150 mg Q2W added to stable LMT for 78 weeks.

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 pre-filled syringe.

Intervention Type

Drug

Intervention Name(s)

Alirocumab

Other Intervention Name(s)

SAR236553, REGN727, Praluent

Intervention Description

Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.

Intervention Type

Drug

Intervention Name(s)

Lipid-Modifying Therapy (LMT)

Intervention Description

Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Experienced Adverse Events (AEs)

Description

Time Frame

Up to 10 weeks after last study drug administration (maximum of 86 weeks)

Secondary 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

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 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 Measured LDL-C at Week 24 - ITT Analysis

Description

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 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).

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

Description

Time Frame

Up to Week 52

Title

Description

Adjusted percentages at Week 24 were 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

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 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 Apo A1 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 A1 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 - 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

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

Title

Percentage of Participants Who Experienced Cardiovascular (CV) Events

Description

CV events included coronary heart disease (CHD) death; non-fatal myocardial infarction (MI); fatal and non-fatal ischemic stroke; unstable angina requiring hospitalization; congestive heart failure (CHF) requiring hospitalization; ischemia-driven coronary revascularization procedure. Reported events are CV events as confirmed by an independent Clinical Events Committee (CEC) that occurred during the treatment emergent period ( i.e. from first dose up to the last dose of study drug + 70 days).

Time Frame

Up to 10 weeks after last study drug administration (maximum of 86 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Either A or B below and who were not adequately controlled with their lipid-modifying therapy: A) Participants with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Participants with hypercholesterolemia together with established CHD or CHD risk equivalents. Exclusion criteria: Age < 18 years LDL-C <70 mg/dL (< 1.81 mmol/L) Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L) The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 840159

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

Investigational Site Number 840028

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85295

Country

United States

Facility Name

Investigational Site Number 840035

City

Sierra Vista

State/Province

Arizona

ZIP/Postal Code

85635

Country

United States

Facility Name

Investigational Site Number 840052

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Investigational Site Number 840065

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Investigational Site Number 840079

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Investigational Site Number 840094

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85282

Country

United States

Facility Name

Investigational Site Number 840103

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741-3565

Country

United States

Facility Name

Investigational Site Number 840209

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90210

Country

United States

Facility Name

Investigational Site Number 840194

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Investigational Site Number 840207

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Investigational Site Number 840101

City

Lincoln

State/Province

California

ZIP/Postal Code

95648

Country

United States

Facility Name

Investigational Site Number 840076

City

Long Beach

State/Province

California

ZIP/Postal Code

90807

Country

United States

Facility Name

Investigational Site Number 840214

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Investigational Site Number 840045

City

Sacramento

State/Province

California

ZIP/Postal Code

95842

Country

United States

Facility Name

Investigational Site Number 840163

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95405

Country

United States

Facility Name

Investigational Site Number 840086

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80906

Country

United States

Facility Name

Investigational Site Number 840077

City

Golden

State/Province

Colorado

ZIP/Postal Code

80401

Country

United States

Facility Name

Investigational Site Number 840224

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06610

Country

United States

Facility Name

Investigational Site Number 840134

City

Guilford

State/Province

Connecticut

ZIP/Postal Code

06437

Country

United States

Facility Name

Investigational Site Number 840246

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

Facility Name

Investigational Site Number 840055

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Investigational Site Number 840091

City

Stamford

State/Province

Connecticut

ZIP/Postal Code

06905

Country

United States

Facility Name

Investigational Site Number 840150

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Investigational Site Number 840020

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34208

Country

United States

Facility Name

Investigational Site Number 840041

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Investigational Site Number 840184

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Investigational Site Number 840242

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Facility Name

Investigational Site Number 840039

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Investigational Site Number 840182

City

Crystal River

State/Province

Florida

ZIP/Postal Code

34429

Country

United States

Facility Name

Investigational Site Number 840002

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Investigational Site Number 840166

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Investigational Site Number 840167

City

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

Investigational Site Number 840018

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33309

Country

United States

Facility Name

Investigational Site Number 840090

City

Ft. Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Investigational Site Number 840153

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Investigational Site Number 840181

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32205

Country

United States

Facility Name

Investigational Site Number 840152

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Investigational Site Number 840154

City

Lake Mary

State/Province

Florida

ZIP/Postal Code

32746

Country

United States

Facility Name

Investigational Site Number 840059

City

Largo

State/Province

Florida

ZIP/Postal Code

33773

Country

United States

Facility Name

Investigational Site Number 840221

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Investigational Site Number 840021

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Investigational Site Number 840122

City

New Smyrna Beach

State/Province

Florida

ZIP/Postal Code

32169

Country

United States

Facility Name

Investigational Site Number 840151

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Investigational Site Number 840108

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Investigational Site Number 840067

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

Investigational Site Number 840006

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33026

Country

United States

Facility Name

Investigational Site Number 840168

City

Ponte Vedra

State/Province

Florida

ZIP/Postal Code

32081

Country

United States

Facility Name

Investigational Site Number 840164

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number 840175

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Investigational Site Number 840001

City

St. Petersburg

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840003

City

St. Petersburg

State/Province

Florida

Country

United States

Facility Name

Investigational Site Number 840036

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Investigational Site Number 840117

City

Cumming

State/Province

Georgia

ZIP/Postal Code

30041

Country

United States

Facility Name

Investigational Site Number 840110

City

Roswell

State/Province

Georgia

ZIP/Postal Code

30076

Country

United States

Facility Name

Investigational Site Number 840026

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Investigational Site Number 840075

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

Investigational Site Number 840027

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Investigational Site Number 840093

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Investigational Site Number 840222

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Investigational Site Number 840165

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Investigational Site Number 840200

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160-7321

Country

United States

Facility Name

Investigational Site Number 840040

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67203

Country

United States

Facility Name

Investigational Site Number 840061

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67205

Country

United States

Facility Name

Investigational Site Number 840032

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Investigational Site Number 840084

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67207

Country

United States

Facility Name

Investigational Site Number 840244

City

Biddeford

State/Province

Maine

ZIP/Postal Code

04005

Country

United States

Facility Name

Investigational Site Number 840158

City

Framingham

State/Province

Maine

ZIP/Postal Code

01702

Country

United States

Facility Name

Investigational Site Number 840193

City

Novi

State/Province

Michigan

ZIP/Postal Code

48374

Country

United States

Facility Name

Investigational Site Number 840162

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48604

Country

United States

Facility Name

Investigational Site Number 840033

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63117

Country

United States

Facility Name

Investigational Site Number 840113

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

Investigational Site Number 840095

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Investigational Site Number 840096

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Investigational Site Number 840022

City

Edison

State/Province

New Jersey

ZIP/Postal Code

08817

Country

United States

Facility Name

Investigational Site Number 840011

City

Hillsborough

State/Province

New Jersey

ZIP/Postal Code

08844

Country

United States

Facility Name

Investigational Site Number 840049

City

Trenton

State/Province

New Jersey

ZIP/Postal Code

08611

Country

United States

Facility Name

Investigational Site Number 840097

City

Bronxville

State/Province

New York

ZIP/Postal Code

10708

Country

United States

Facility Name

Investigational Site Number 840129

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

Investigational Site Number 840160

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Investigational Site Number 840217

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Investigational Site Number 840023

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28211

Country

United States

Facility Name

Investigational Site Number 840083

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Investigational Site Number 840104

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

Investigational Site Number 840068

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Investigational Site Number 840007

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

Investigational Site Number 840013

City

Marion

State/Province

Ohio

ZIP/Postal Code

43302

Country

United States

Facility Name

Investigational Site Number 840161

City

Mentor

State/Province

Ohio

ZIP/Postal Code

44060

Country

United States

Facility Name

Investigational Site Number 840005

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Investigational Site Number 840170

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Investigational Site Number 840180

City

Camp Hill

State/Province

Pennsylvania

ZIP/Postal Code

17011

Country

United States

Facility Name

Investigational Site Number 840004

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Investigational Site Number 840046

City

Jersey Shore

State/Province

Pennsylvania

ZIP/Postal Code

17740

Country

United States

Facility Name

Investigational Site Number 840155

City

Phoenixville

State/Province

Pennsylvania

ZIP/Postal Code

19460

Country

United States

Facility Name

Investigational Site Number 840177

City

Scranton

State/Province

Pennsylvania

ZIP/Postal Code

18508

Country

United States

Facility Name

Investigational Site Number 840202

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Investigational Site Number 840073

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Investigational Site Number 840087

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Investigational Site Number 840074

City

Simpsonville

State/Province

South Carolina

ZIP/Postal Code

29681

Country

United States

Facility Name

Investigational Site Number 840105

City

Varnville

State/Province

South Carolina

ZIP/Postal Code

29944

Country

United States

Facility Name

Investigational Site Number 840190

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37917

Country

United States

Facility Name

Investigational Site Number 840092

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

Investigational Site Number 840212

City

Dallas

State/Province

Texas

ZIP/Postal Code

75226

Country

United States

Facility Name

Investigational Site Number 840058

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Investigational Site Number 840149

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Investigational Site Number 840070

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76117

Country

United States

Facility Name

Investigational Site Number 840038

City

Houston

State/Province

Texas

ZIP/Postal Code

77024

Country

United States

Facility Name

Investigational Site Number 840047

City

Houston

State/Province

Texas

ZIP/Postal Code

77074

Country

United States

Facility Name

Investigational Site Number 840053

City

Plano

State/Province

Texas

ZIP/Postal Code

75023

Country

United States

Facility Name

Investigational Site Number 840072

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Investigational Site Number 840241

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Facility Name

Investigational Site Number 840031

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Investigational Site Number 840204

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Investigational Site Number 840120

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Investigational Site Number 840111

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53209-0996

Country

United States

Facility Name

Investigational Site Number 032006

City

Buenos Aires

ZIP/Postal Code

C1425DES

Country

Argentina

Facility Name

Investigational Site Number 032010

City

Caba

ZIP/Postal Code

C1440AAD

Country

Argentina

Facility Name

Investigational Site Number 032008

City

Capital Federal

ZIP/Postal Code

1119

Country

Argentina

Facility Name

Investigational Site Number 032001

City

Coronel Suarez

ZIP/Postal Code

B7540GHD

Country

Argentina

Facility Name

Investigational Site Number 032004

City

Resistencia

ZIP/Postal Code

H3500CDM

Country

Argentina

Facility Name

Investigational Site Number 032007

City

Zarate

ZIP/Postal Code

B2800DGH

Country

Argentina

Facility Name

Investigational Site Number 056005

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Investigational Site Number 056004

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Natoye

ZIP/Postal Code

5360

Country

Belgium

Facility Name

Investigational Site Number 056002

City

Wetteren

ZIP/Postal Code

9230

Country

Belgium

Facility Name

Investigational Site Number 100008

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Investigational Site Number 100014

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Investigational Site Number 100005

City

Sofia

ZIP/Postal Code

1203

Country

Bulgaria

Facility Name

Investigational Site Number 100012

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Investigational Site Number 100015

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Investigational Site Number 100009

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Investigational Site Number 100001

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Investigational Site Number 100013

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Investigational Site Number 100007

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Investigational Site Number 124013

City

Cambridge

ZIP/Postal Code

N1R 6V6

Country

Canada

Facility Name

Investigational Site Number 124027

City

Coquitlam

ZIP/Postal Code

V3K 3P4

Country

Canada

Facility Name

Investigational Site Number 124001

City

Hawkesbury

ZIP/Postal Code

K6A 1A1

Country

Canada

Facility Name

Investigational Site Number 124002

City

London

ZIP/Postal Code

N5W 6A2

Country

Canada

Facility Name

Investigational Site Number 124009

City

Mirabel

ZIP/Postal Code

J7J 2K8

Country

Canada

Facility Name

Investigational Site Number 124018

City

Montreal

ZIP/Postal Code

H1T 3Y7

Country

Canada

Facility Name

Investigational Site Number 124007

City

Ottawa

ZIP/Postal Code

K1K 4L2

Country

Canada

Facility Name

Investigational Site Number 124011

City

Quebec

ZIP/Postal Code

G1V 4M6

Country

Canada

Facility Name

Investigational Site Number 124005

City

Saint John'S

ZIP/Postal Code

A1A 3R5

Country

Canada

Facility Name

Investigational Site Number 124008

City

Sarnia

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Investigational Site Number 124022

City

Terrebonne

ZIP/Postal Code

J6V 1S8

Country

Canada

Facility Name

Investigational Site Number 124003

City

Vancouver

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

Investigational Site Number 124006

City

Victoria

ZIP/Postal Code

V8T 5G4

Country

Canada

Facility Name

Investigational Site Number 124015

City

Woodstock

ZIP/Postal Code

N4S 5P5

Country

Canada

Facility Name

Investigational Site Number 152007

City

Osorno

ZIP/Postal Code

5311092

Country

Chile

Facility Name

Investigational Site Number 152008

City

Santiago

ZIP/Postal Code

7980378

Country

Chile

Facility Name

Investigational Site Number 152006

City

Santiago

ZIP/Postal Code

8053095

Country

Chile

Facility Name

Investigational Site Number 152004

City

Temuco

ZIP/Postal Code

4790869

Country

Chile

Facility Name

Investigational Site Number 170004

City

Barranquilla

Country

Colombia

Facility Name

Investigational Site Number 170005

City

Barranquilla

Country

Colombia

Facility Name

Investigational Site Number 170008

City

Barranquilla

Country

Colombia

Facility Name

Investigational Site Number 170001

City

Manizales

Country

Colombia

Facility Name

Investigational Site Number 170003

City

Medellin

Country

Colombia

Facility Name

Investigational Site Number 203004

City

Praha 2

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

Investigational Site Number 203007

City

Praha 5

ZIP/Postal Code

15006

Country

Czech Republic

Facility Name

Investigational Site Number 203006

City

Praha 5

ZIP/Postal Code

15800

Country

Czech Republic

Facility Name

Investigational Site Number 208005

City

Aarhus

ZIP/Postal Code

8200

Country

Denmark

Facility Name

Investigational Site Number 208004

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

Facility Name

Investigational Site Number 208003

City

Slagelse

ZIP/Postal Code

4200

Country

Denmark

Facility Name

Investigational Site Number 208001

City

Svendborg

ZIP/Postal Code

5700

Country

Denmark

Facility Name

Investigational Site Number 208002

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

Facility Name

Investigational Site Number 246002

City

Joensuu

ZIP/Postal Code

80100

Country

Finland

Facility Name

Investigational Site Number 246001

City

Kokkola

ZIP/Postal Code

67100

Country

Finland

Facility Name

Investigational Site Number 246003

City

Kuopio

ZIP/Postal Code

70210

Country

Finland

Facility Name

Investigational Site Number 246004

City

Vantaa

ZIP/Postal Code

01600

Country

Finland

Facility Name

Investigational Site Number 250007

City

Bandol

ZIP/Postal Code

83150

Country

France

Facility Name

Investigational Site Number 250003

City

Broglie

ZIP/Postal Code

27270

Country

France

Facility Name

Investigational Site Number 250014

City

Bron Cedex

ZIP/Postal Code

69677

Country

France

Facility Name

Investigational Site Number 250004

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Investigational Site Number 250006

City

Lille Cedex

ZIP/Postal Code

59037

Country

France

Facility Name

Investigational Site Number 250009

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 250001

City

Nantes

ZIP/Postal Code

44300

Country

France

Facility Name

Investigational Site Number 250002

City

Paris Cedex 13

ZIP/Postal Code

75651

Country

France

Facility Name

Investigational Site Number 250010

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Investigational Site Number 250012

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

Investigational Site Number 250005

City

Vieux Conde

ZIP/Postal Code

59690

Country

France

Facility Name

Investigational Site Number 250008

City

Vihiers

ZIP/Postal Code

49310

Country

France

Facility Name

Investigational Site Number 276001

City

Bad Wörishofen

ZIP/Postal Code

86825

Country

Germany

Facility Name

Investigational Site Number 276007

City

Berlin

ZIP/Postal Code

12627

Country

Germany

Facility Name

Investigational Site Number 276005

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Investigational Site Number 276014

City

Berlin

ZIP/Postal Code

13158

Country

Germany

Facility Name

Investigational Site Number 276008

City

Bochum

ZIP/Postal Code

44787

Country

Germany

Facility Name

Investigational Site Number 276009

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Investigational Site Number 276004

City

Essen

ZIP/Postal Code

45355

Country

Germany

Facility Name

Investigational Site Number 276010

City

Frankfurt A.M.

ZIP/Postal Code

60596

Country

Germany

Facility Name

Investigational Site Number 276011

City

Görlitz

ZIP/Postal Code

02826

Country

Germany

Facility Name

Investigational Site Number 276019

City

Hannover

ZIP/Postal Code

30159

Country

Germany

Facility Name

Investigational Site Number 276013

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Investigational Site Number 276012

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Investigational Site Number 276003

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Investigational Site Number 276006

City

Schwerin

ZIP/Postal Code

19055

Country

Germany

Facility Name

Investigational Site Number 276015

City

Witten

ZIP/Postal Code

58455

Country

Germany

Facility Name

Investigational Site Number 348003

City

Baja

ZIP/Postal Code

6500

Country

Hungary

Facility Name

Investigational Site Number 348007

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 348009

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Investigational Site Number 348008

City

Budapest

ZIP/Postal Code

1135

Country

Hungary

Facility Name

Investigational Site Number 348013

City

Budapest

ZIP/Postal Code

1136

Country

Hungary

Facility Name

Investigational Site Number 348004

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 348002

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

Investigational Site Number 348006

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Investigational Site Number 348001

City

Sopron

ZIP/Postal Code

9400

Country

Hungary

Facility Name

Investigational Site Number 348011

City

Urhida

ZIP/Postal Code

8142

Country

Hungary

Facility Name

Investigational Site Number 376002

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Investigational Site Number 376003

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Investigational Site Number 376005

City

Holon

ZIP/Postal Code

58100

Country

Israel

Facility Name

Investigational Site Number 376004

City

Nazareth

ZIP/Postal Code

16100

Country

Israel

Facility Name

Investigational Site Number 380006

City

Chieti

ZIP/Postal Code

66013

Country

Italy

Facility Name

Investigational Site Number 380002

City

Cinisello Balsamo

ZIP/Postal Code

20092

Country

Italy

Facility Name

Investigational Site Number 380009

City

Milano

ZIP/Postal Code

20138

Country

Italy

Facility Name

Investigational Site Number 380007

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Investigational Site Number 380001

City

Palermo

ZIP/Postal Code

90127

Country

Italy

Facility Name

Investigational Site Number 380005

City

Pozzilli

ZIP/Postal Code

86077

Country

Italy

Facility Name

Investigational Site Number 380008

City

Vittorio Veneto

ZIP/Postal Code

31029

Country

Italy

Facility Name

Investigational Site Number 380010

City

Zingonia-Osio Sotto

Country

Italy

Facility Name

Investigational Site Number 484010

City

ZIP/Postal Code

03300

Country

Mexico

Facility Name

Investigational Site Number 484004

City

Mexico

ZIP/Postal Code

06090

Country

Mexico

Facility Name

Investigational Site Number 484008

City

Not Provided

Country

Mexico

Facility Name

Investigational Site Number 484001

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Investigational Site Number 484002

City

Tijuana

ZIP/Postal Code

22500

Country

Mexico

Facility Name

Investigational Site Number 484009

City

Torreon

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Investigational Site Number 484003

City

Xalapa

ZIP/Postal Code

91020

Country

Mexico

Facility Name

Investigational Site Number 528013

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

Facility Name

Investigational Site Number 528001

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Investigational Site Number 528004

City

Breda

ZIP/Postal Code

4811 SW

Country

Netherlands

Facility Name

Investigational Site Number 528005

City

Eindhoven

ZIP/Postal Code

5616GB

Country

Netherlands

Facility Name

Investigational Site Number 528007

City

Groningen

ZIP/Postal Code

9711 SG

Country

Netherlands

Facility Name

Investigational Site Number 528011

City

Hoogeveen

ZIP/Postal Code

7909 AA

Country

Netherlands

Facility Name

Investigational Site Number 528002

City

Hoorn

ZIP/Postal Code

1625 HV

Country

Netherlands

Facility Name

Investigational Site Number 528008

City

Leiderdorp

ZIP/Postal Code

2352 RA

Country

Netherlands

Facility Name

Investigational Site Number 528009

City

Rotterdam

ZIP/Postal Code

3021 HC

Country

Netherlands

Facility Name

Investigational Site Number 528006

City

Velp

ZIP/Postal Code

6883 ES

Country

Netherlands

Facility Name

Investigational Site Number 528012

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

Investigational Site Number 528010

City

Zoetermeer

ZIP/Postal Code

2724 EK

Country

Netherlands

Facility Name

Investigational Site Number 578005

City

Elverum

ZIP/Postal Code

2402

Country

Norway

Facility Name

Investigational Site Number 578001

City

Hamar

ZIP/Postal Code

2317

Country

Norway

Facility Name

Investigational Site Number 578002

City

Oslo

Country

Norway

Facility Name

Investigational Site Number 578004

City

Skedsmokorset

ZIP/Postal Code

2020

Country

Norway

Facility Name

Investigational Site Number 578003

City

Stavanger

ZIP/Postal Code

4005

Country

Norway

Facility Name

Investigational Site Number 616008

City

Gdynia

ZIP/Postal Code

81-384

Country

Poland

Facility Name

Investigational Site Number 616003

City

Gdynia

ZIP/Postal Code

81423

Country

Poland

Facility Name

Investigational Site Number 616001

City

Gniewkowo

ZIP/Postal Code

88-140

Country

Poland

Facility Name

Investigational Site Number 616010

City

Katowice

ZIP/Postal Code

40-748

Country

Poland

Facility Name

Investigational Site Number 616018

City

Krakow

ZIP/Postal Code

31-315

Country

Poland

Facility Name

Investigational Site Number 616004

City

Piotrkow Trybunalski

ZIP/Postal Code

97-300

Country

Poland

Facility Name

Investigational Site Number 616013

City

Pulawy

ZIP/Postal Code

24-100

Country

Poland

Facility Name

Investigational Site Number 616009

City

Warszawa

ZIP/Postal Code

02-777

Country

Poland

Facility Name

Investigational Site Number 616007

City

Wroclaw

ZIP/Postal Code

50-088

Country

Poland

Facility Name

Investigational Site Number 620006

City

Funchal / Madeira

ZIP/Postal Code

9050

Country

Portugal

Facility Name

Investigational Site Number 620002

City

Lisboa

ZIP/Postal Code

1169-024

Country

Portugal

Facility Name

Investigational Site Number 620001

City

Lisboa

ZIP/Postal Code

1549-008

Country

Portugal

Facility Name

Investigational Site Number 620005

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Investigational Site Number 642005

City

Baia Mare

ZIP/Postal Code

430031

Country

Romania

Facility Name

Investigational Site Number 642002

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Investigational Site Number 642004

City

Targu Mures

ZIP/Postal Code

540099

Country

Romania

Facility Name

Investigational Site Number 642001

City

Timisoara

ZIP/Postal Code

300358

Country

Romania

Facility Name

Investigational Site Number 643005

City

Barnaul

Country

Russian Federation

Facility Name

Investigational Site Number 643012

City

Moscow

ZIP/Postal Code

119415

Country

Russian Federation

Facility Name

Investigational Site Number 643008

City

Moscow

ZIP/Postal Code

125284

Country

Russian Federation

Facility Name

Investigational Site Number 643014

City

Perm

ZIP/Postal Code

614097

Country

Russian Federation

Facility Name

Investigational Site Number 643006

City

St Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Investigational Site Number 643009

City

St.Petersburg

ZIP/Postal Code

196084

Country

Russian Federation

Facility Name

Investigational Site Number 643004

City

Yaroslavl

ZIP/Postal Code

150002

Country

Russian Federation

Facility Name

Investigational Site Number 710010

City

Centurion

ZIP/Postal Code

0158

Country

South Africa

Facility Name

Investigational Site Number 710008

City

Meyerspark

ZIP/Postal Code

0184

Country

South Africa

Facility Name

Investigational Site Number 710011

City

Middelburg

ZIP/Postal Code

1055

Country

South Africa

Facility Name

Investigational Site Number 710006

City

Parktown

ZIP/Postal Code

2193

Country

South Africa

Facility Name

Investigational Site Number 710004

City

Pretoria

ZIP/Postal Code

0002

Country

South Africa

Facility Name

Investigational Site Number 710001

City

Pretoria

ZIP/Postal Code

0084

Country

South Africa

Facility Name

Investigational Site Number 710002

City

Pretoria

ZIP/Postal Code

181

Country

South Africa

Facility Name

Investigational Site Number 710009

City

Roodepoort

ZIP/Postal Code

1724

Country

South Africa

Facility Name

Investigational Site Number 710003

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

Investigational Site Number 710005

City

Witbank

Country

South Africa

Facility Name

Investigational Site Number 710007

City

Worcester

ZIP/Postal Code

6850

Country

South Africa

Facility Name

Investigational Site Number 724006

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Investigational Site Number 724003

City

Granada

ZIP/Postal Code

18012

Country

Spain

Facility Name

Investigational Site Number 724002

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Investigational Site Number 724007

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724008

City

Quart De Poblet

ZIP/Postal Code

46930

Country

Spain

Facility Name

Investigational Site Number 724005

City

Reus

ZIP/Postal Code

43201

Country

Spain

Facility Name

Investigational Site Number 724001

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

Investigational Site Number 724004

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Investigational Site Number 752002

City

Rättvik

ZIP/Postal Code

79530

Country

Sweden

Facility Name

Investigational Site Number 752006

City

Stockholm

ZIP/Postal Code

111 35

Country

Sweden

Facility Name

Investigational Site Number 752003

City

Stockholm

ZIP/Postal Code

111 57

Country

Sweden

Facility Name

Investigational Site Number 752004

City

Stockholm

ZIP/Postal Code

14186

Country

Sweden

Facility Name

Investigational Site Number 752001

City

Örebro

ZIP/Postal Code

70146

Country

Sweden

Facility Name

Investigational Site Number 804012

City

Chernivtsi

ZIP/Postal Code

58013

Country

Ukraine

Facility Name

Investigational Site Number 804003

City

Dnipropetrovsk

ZIP/Postal Code

49006

Country

Ukraine

Facility Name

Investigational Site Number 804002

City

Donetsk

ZIP/Postal Code

83114

Country

Ukraine

Facility Name

Investigational Site Number 804014

City

Kharkiv

ZIP/Postal Code

61002

Country

Ukraine

Facility Name

Investigational Site Number 804016

City

Kiev

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Investigational Site Number 804011

City

Kyiv

ZIP/Postal Code

01103

Country

Ukraine

Facility Name

Investigational Site Number 804010

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Investigational Site Number 804001

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Investigational Site Number 804008

City

Kyiv

ZIP/Postal Code

04053

Country

Ukraine

Facility Name

Investigational Site Number 804013

City

Kyiv

Country

Ukraine

Facility Name

Investigational Site Number 804005

City

Zhytomyr

ZIP/Postal Code

10002

Country

Ukraine

Facility Name

Investigational Site Number 826004

City

Addlestone

ZIP/Postal Code

KT15 2BH

Country

United Kingdom

Facility Name

Investigational Site Number 826009

City

Birmingham

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

Facility Name

Investigational Site Number 826016

City

Birmingham

ZIP/Postal Code

B18 7QH

Country

United Kingdom

Facility Name

Investigational Site Number 826021

City

Blackpool

ZIP/Postal Code

FY3 7EN

Country

United Kingdom

Facility Name

Investigational Site Number 826023

City

Cambridge

ZIP/Postal Code

CB2 OQQ

Country

United Kingdom

Facility Name

Investigational Site Number 826012

City

Cardiff

ZIP/Postal Code

CF14 5GJ

Country

United Kingdom

Facility Name

Investigational Site Number 826024

City

Chichester

ZIP/Postal Code

PO19 4SE

Country

United Kingdom

Facility Name

Investigational Site Number 826006

City

Chorley

ZIP/Postal Code

PR7 7NA

Country

United Kingdom

Facility Name

Investigational Site Number 826010

City

Glasgow

ZIP/Postal Code

G20 0SP

Country

United Kingdom

Facility Name

Investigational Site Number 826003

City

Irvine

ZIP/Postal Code

KA12 0AY

Country

United Kingdom

Facility Name

Investigational Site Number 826008

City

Liverpool

ZIP/Postal Code

L22 0LG

Country

United Kingdom

Facility Name

Investigational Site Number 826005

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Investigational Site Number 826025

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Investigational Site Number 826007

City

Manchester

ZIP/Postal Code

M15 6SX

Country

United Kingdom

Facility Name

Investigational Site Number 826001

City

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

Investigational Site Number 826019

City

Penzance

ZIP/Postal Code

TR19 7HH

Country

United Kingdom

Facility Name

Investigational Site Number 826011

City

Reading

ZIP/Postal Code

RG2 7AG

Country

United Kingdom

Facility Name

Investigational Site Number 826013

City

Romford

ZIP/Postal Code

RM7 0AG

Country

United Kingdom

Facility Name

Investigational Site Number 826014

City

Soham

ZIP/Postal Code

CB7 5JD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25773378

Citation

Robinson JG, Farnier M, Krempf M, Bergeron J, Luc G, Averna M, Stroes ES, Langslet G, Raal FJ, El Shahawy M, Koren MJ, Lepor NE, Lorenzato C, Pordy R, Chaudhari U, Kastelein JJ; ODYSSEY LONG TERM Investigators. Efficacy and safety of alirocumab in reducing lipids and cardiovascular events. N Engl J Med. 2015 Apr 16;372(16):1489-99. doi: 10.1056/NEJMoa1501031. Epub 2015 Mar 15.

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

Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

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Long-term Safety and Tolerability of Alirocumab (SAR236553/REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)

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