Back to results

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60) (LATITUDE)

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Losmapimod 7.5 mg twice daily

Placebo twice daily

Standard therapy

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Myocardial infarction, Acute coronary syndrome, Cardiovascular disease, p38 mitogen-activated protein kinase (MAPK) inhibitor, NSTEMI, Losmapimod, STEMI

Eligibility Criteria

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

Inclusion Criteria:

Signed written informed consent
Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy
Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI)
With the following timing of symptoms: NSTEMI: Presence of ischemic symptoms (>=5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode). STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization.
At least one of the following
Age >=60 years at randomization.
Myocardial infarction prior to the qualifying ACS event
CABG prior to qualifying ACS event.
NSTEMI with new ischemic ST-segment depression >= 0.1 mV in >= 2 contiguous leads.
Diabetes mellitus requiring pharmacotherapy.
Coexistent clinically diagnosed arterial disease

Exclusion Criteria:

Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
Current severe heart failure or shock
Ongoing clinical instability
History of chronic liver disease
Known severe renal impairment
Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study.
Known active tuberculosis, HIV, active opportunistic or life threatening infections.
Vaccination with a live attenuated vaccine within 6 weeks of randomization.
Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents
Positive pregnancy test or is known to be pregnant or lactating
Known alcohol or drug abuse within the past 6 months
Any current mental condition, which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study.
Participation in a study of an investigational medication within the past 30 days.
Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks.
Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study
Any other reason the investigator deems the subject to be unsuitable for the study

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Losmapimod

Placebo

Arm Description

Losmapimod 7.5 mg twice daily oral tablet

Placebo twice daily oral tablet

Outcomes

Primary Outcome Measures

Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12

The primary efficacy endpoint is the composite measure of adjudicated MACE that includes the time to first occurrence of CV death (death due to a cardiovascular cause), MI or SRI-UR (Severe Recurrent Ischemia requiring Urgent coronary artery Revascularization). Death for which the Clinical Events Committee (CEC) or investigator were unable to establish cause were analyzed as CV deaths.

Secondary Outcome Measures

Number of Participants With First Occurrence of MACE Through Week 24

Number of participants with first occurrence of MACE through Week 24 including CV death, MI or SRI-UR are presented. Death for which the CEC or investigator were unable to establish cause were analyzed as CV deaths.

Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24

Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.

Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.

Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24

Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of coronary events defined as coronary heart disease (CHD) death, MI, SRI-UR or any unplanned coronary artery revascularization through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24

Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24

Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24

Number of participants with first occurrence of definite or probable stent thrombosis through to Week 12 and Week 24 are presented. Participants receiving stent prior to randomization or during the study prior to Week 12 were included.

Number of Participants Re-hospitalized Within 30 Days of Discharge

Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.

Number of Participants With All-cause Mortality Through to Week 12 and Week 24

Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.

Number of Participants With CV Death Events Through to Week 12 and Week 24

Number of participants with CV death events through to Week 12 and Week 24 are presented.

Number of Participants With CHD Death Events Through to Week 12 and Week 24

Number of participants with CHD death events through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24

Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24

Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24

Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24

Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24

Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.

Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24

Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.

Full Information

NCT ID

NCT02145468

First Posted

May 15, 2014

Last Updated

April 27, 2017

Sponsor

GlaxoSmithKline

Collaborators

The TIMI Study Group

1. Study Identification

Unique Protocol Identification Number

NCT02145468

Brief Title

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

Acronym

LATITUDE

Official Title

A Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (PM1116197) LosmApimod To Inhibit p38 MAP Kinase as a TherapeUtic Target and moDify Outcomes After an Acute Coronary syndromE (LATITUDE)-TIMI 60.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

June 3, 2014 (Actual)

Primary Completion Date

December 14, 2015 (Actual)

Study Completion Date

December 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

The TIMI Study Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.

6. Conditions and Keywords

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

Acute Coronary Syndrome

Keywords

Myocardial infarction, Acute coronary syndrome, Cardiovascular disease, p38 mitogen-activated protein kinase (MAPK) inhibitor, NSTEMI, Losmapimod, STEMI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

3503 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Losmapimod

Arm Type

Experimental

Arm Description

Losmapimod 7.5 mg twice daily oral tablet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo twice daily oral tablet

Intervention Type

Drug

Intervention Name(s)

Losmapimod 7.5 mg twice daily

Other Intervention Name(s)

GW856553

Intervention Description

Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.

Intervention Type

Drug

Intervention Name(s)

Placebo twice daily

Intervention Description

Subjects will receive placebo as film-coated, round, plain faced tablets.

Intervention Type

Drug

Intervention Name(s)

Standard therapy

Intervention Description

Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.

Primary Outcome Measure Information:

Title

Number of Participants With First Occurrence of Major Adverse Cardiovascular Events (MACE) Through Week 12

Description

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With First Occurrence of MACE Through Week 24

Description

Time Frame

Up to Week 24

Title

Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24

Description

Week 12 results are considered the principal secondary endpoint. Number of participants with first occurrence of the composite of CV death or MI up to Week 12 and Week 24 are summarized.

Time Frame

Week 12 and Week 24

Title

Number of Participants With First Occurrence of the Composite of CV Death, MI or Hospitalization for Heart Failure (HF) up to Week 12 and Week 24.

Description

Number of participants with first occurrence of the composite of CV death, MI or hospitalization for HF up to Week 12 and Week 24 are presented.

Time Frame

Week 12 and Week 24

Title

Number of Participants With First Occurrence of the Expanded Composite of Arterial CV Events Defined as CV Death, MI, SRI-UR or Stroke Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the expanded composite of arterial CV events defined as CV death, MI, SRI-UR or stroke through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of Coronary Events Defined as CHD Death, MI, SRI-UR or Any Unplanned Coronary Artery Revascularization Through to Week 12 and Week 24

Description

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of CV Death or Hospitalization for HF Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of CV death or hospitalization for HF through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of CV Death, MI or Stroke Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of CV death, MI or stroke through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Expanded Composite of CV Death, MI, SRI-UR, Stroke or Hospitalization for HF Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the expanded composite of CV death, MI, SRI-UR, stroke or hospitalization for HF through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of CHD Death, MI or SRI-UR Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of CHD death, MI or SRI-UR through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of CHD Death or MI Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of CHD death or MI through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of All-cause Death, MI or SRI-UR Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of all-cause death, MI or SRI-UR through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of All-cause Death or MI Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of all-cause death or MI through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of CV Death, Type I (Spontaneous) MI or SRI-UR Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of CV death, type I (spontaneous) MI or SRI-UR through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of the Composite of CV Death or Type I (Spontaneous) MI Through to Week 12 and Week 24

Description

Number of participants with first occurrence of the composite of CV death or type I (spontaneous) MI through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of Definite or Probable Stent Thrombosis Through to Week 12 and Week 24

Description

Time Frame

Week 12, Week 24

Title

Number of Participants Re-hospitalized Within 30 Days of Discharge

Description

Participants who had a death or re-hospitalization within 30 days of discharge, plus participants who were never discharged from the initial hospitalization were included.

Time Frame

Within up to 30 days of post discharge

Title

Number of Participants With All-cause Mortality Through to Week 12 and Week 24

Description

Number of participants with all-cause mortality through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With CV Death Events Through to Week 12 and Week 24

Description

Number of participants with CV death events through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With CHD Death Events Through to Week 12 and Week 24

Description

Number of participants with CHD death events through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of Myocardial Infarction (Fatal and Non-fatal) Events Through to Week 12 and Week 24

Description

Number of participants with first occurrence of myocardial infarction (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of Type I (Spontaneous) MI Events Through to Week 12 and Week 24

Description

Number of participants with first occurrence of type I (spontaneous) MI events through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of SRI-UR Events Through to Week 12 and Week 24

Description

Number of participants with first occurrence of SRI-UR events through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of Stroke (Fatal and Non-fatal) Events Through to Week 12 and Week 24

Description

Number of participants with first occurrence of stroke (fatal and non-fatal) events through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of Hospitalization for HF Through to Week 12 and Week 24

Description

Number of participants with first occurrence of hospitalization for HF through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

Title

Number of Participants With First Occurrence of Any Unplanned Coronary Revascularization Through to Week 12 and Week 24

Description

Number of participants with first occurrence of any unplanned coronary revascularization through to Week 12 and Week 24 are presented.

Time Frame

Week 12, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed written informed consent Men or women at least 35 years old. Women must be post-menopausal or using a highly effective method for avoidance of pregnancy Hospitalization for NSTEMI or STEMI (Universal Definition Type 1 MI) With the following timing of symptoms: NSTEMI: Presence of ischemic symptoms (>=5 minutes) at rest within 24 hours prior to randomization (may include qualifying episode). STEMI: Onset of qualifying ischemic symptoms within 12 hours of randomization. At least one of the following Age >=60 years at randomization. Myocardial infarction prior to the qualifying ACS event CABG prior to qualifying ACS event. NSTEMI with new ischemic ST-segment depression >= 0.1 mV in >= 2 contiguous leads. Diabetes mellitus requiring pharmacotherapy. Coexistent clinically diagnosed arterial disease Exclusion Criteria: Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI. Current severe heart failure or shock Ongoing clinical instability History of chronic liver disease Known severe renal impairment Any condition, other than vascular disease, with life expectancy <1 year that might prevent the subject from completing the study. Known active tuberculosis, HIV, active opportunistic or life threatening infections. Vaccination with a live attenuated vaccine within 6 weeks of randomization. Concomitant use of cytotoxic chemotherapy for cancer or known ongoing or anticipated use of chronic severe immunosuppressive agents Positive pregnancy test or is known to be pregnant or lactating Known alcohol or drug abuse within the past 6 months Any current mental condition, which may affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study. Participation in a study of an investigational medication within the past 30 days. Anticipated inability to comply with any study procedures, including participation in study visits according to the visit schedule through 24 weeks. Use of another investigational product within 30 days or 5 half-lives (whichever is longer) or according to local regulations, or currently participating in a study of an investigational device. Subjects must be randomized only one time in this investigational study Any other reason the investigator deems the subject to be unsuitable for the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801

Country

United States

Facility Name

GSK Investigational Site

City

Cottonwood

State/Province

Arizona

ZIP/Postal Code

86326

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85713

Country

United States

Facility Name

GSK Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

GSK Investigational Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93308

Country

United States

Facility Name

GSK Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

GSK Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

GSK Investigational Site

City

Mission Viejo

State/Province

California

ZIP/Postal Code

92691

Country

United States

Facility Name

GSK Investigational Site

City

Monterey

State/Province

California

ZIP/Postal Code

93940

Country

United States

Facility Name

GSK Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

Facility Name

GSK Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90509

Country

United States

Facility Name

GSK Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

GSK Investigational Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

GSK Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville Beach

State/Province

Florida

ZIP/Postal Code

32250

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

GSK Investigational Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

GSK Investigational Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

GSK Investigational Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32501

Country

United States

Facility Name

GSK Investigational Site

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

GSK Investigational Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

GSK Investigational Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

GSK Investigational Site

City

Rome

State/Province

Georgia

ZIP/Postal Code

30165

Country

United States

Facility Name

GSK Investigational Site

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

Country

United States

Facility Name

GSK Investigational Site

City

Aurora

State/Province

Illinois

ZIP/Postal Code

60504

Country

United States

Facility Name

GSK Investigational Site

City

Elmhurst

State/Province

Illinois

ZIP/Postal Code

60126

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

GSK Investigational Site

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47303

Country

United States

Facility Name

GSK Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52240

Country

United States

Facility Name

GSK Investigational Site

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

GSK Investigational Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

GSK Investigational Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70809

Country

United States

Facility Name

GSK Investigational Site

City

Slidell

State/Province

Louisiana

ZIP/Postal Code

70458

Country

United States

Facility Name

GSK Investigational Site

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791

Country

United States

Facility Name

GSK Investigational Site

City

Auburn

State/Province

Maine

ZIP/Postal Code

04210

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

GSK Investigational Site

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

GSK Investigational Site

City

Grand Blanc

State/Province

Michigan

ZIP/Postal Code

48439

Country

United States

Facility Name

GSK Investigational Site

City

Marquette

State/Province

Michigan

ZIP/Postal Code

49855

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

Michigan

ZIP/Postal Code

48307

Country

United States

Facility Name

GSK Investigational Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

GSK Investigational Site

City

Ypsilanti

State/Province

Michigan

ZIP/Postal Code

48197

Country

United States

Facility Name

GSK Investigational Site

City

Duluth

State/Province

Minnesota

ZIP/Postal Code

55805

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55407

Country

United States

Facility Name

GSK Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

GSK Investigational Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65804

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

GSK Investigational Site

City

Flemington

State/Province

New Jersey

ZIP/Postal Code

08822

Country

United States

Facility Name

GSK Investigational Site

City

Ridgewood

State/Province

New Jersey

ZIP/Postal Code

07450

Country

United States

Facility Name

GSK Investigational Site

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

GSK Investigational Site

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

GSK Investigational Site

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

GSK Investigational Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

GSK Investigational Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

GSK Investigational Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27401

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27610

Country

United States

Facility Name

GSK Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44710

Country

United States

Facility Name

GSK Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

45215

Country

United States

Facility Name

GSK Investigational Site

City

Mansfield

State/Province

Ohio

ZIP/Postal Code

44906

Country

United States

Facility Name

GSK Investigational Site

City

Zanesville

State/Province

Ohio

ZIP/Postal Code

43701

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73135

Country

United States

Facility Name

GSK Investigational Site

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

GSK Investigational Site

City

Chambersburg

State/Province

Pennsylvania

ZIP/Postal Code

17201

Country

United States

Facility Name

GSK Investigational Site

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822-2160

Country

United States

Facility Name

GSK Investigational Site

City

Doylestown

State/Province

Pennsylvania

ZIP/Postal Code

18901

Country

United States

Facility Name

GSK Investigational Site

City

Wilkes-Barre

State/Province

Pennsylvania

ZIP/Postal Code

18702

Country

United States

Facility Name

GSK Investigational Site

City

York

State/Province

Pennsylvania

ZIP/Postal Code

17403

Country

United States

Facility Name

GSK Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

GSK Investigational Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

GSK Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404-1173

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37205

Country

United States

Facility Name

GSK Investigational Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78756

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75216

Country

United States

Facility Name

GSK Investigational Site

City

Round Rock

State/Province

Texas

ZIP/Postal Code

78681

Country

United States

Facility Name

GSK Investigational Site

City

Victoria

State/Province

Texas

ZIP/Postal Code

77901

Country

United States

Facility Name

GSK Investigational Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Facility Name

GSK Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

GSK Investigational Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26506

Country

United States

Facility Name

GSK Investigational Site

City

Manitowoc

State/Province

Wisconsin

ZIP/Postal Code

54220

Country

United States

Facility Name

GSK Investigational Site

City

Wausau

State/Province

Wisconsin

ZIP/Postal Code

54401

Country

United States

Facility Name

GSK Investigational Site

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878DFK

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSR

Country

Argentina

Facility Name

GSK Investigational Site

City

Venado Tuerto

State/Province

Santa Fe

ZIP/Postal Code

2600

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1428DCO

Country

Argentina

Facility Name

GSK Investigational Site

City

Corrientes

ZIP/Postal Code

W3400AMZ

Country

Argentina

Facility Name

GSK Investigational Site

City

Santa Fe

ZIP/Postal Code

S3000AZG

Country

Argentina

Facility Name

GSK Investigational Site

City

Brisbane

State/Province

Queensland

ZIP/Postal Code

4032

Country

Australia

Facility Name

GSK Investigational Site

City

Cairns

State/Province

Queensland

ZIP/Postal Code

4870

Country

Australia

Facility Name

GSK Investigational Site

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

GSK Investigational Site

City

Nambour

State/Province

Queensland

ZIP/Postal Code

4560

Country

Australia

Facility Name

GSK Investigational Site

City

Bedford Park

State/Province

South Australia

ZIP/Postal Code

5042

Country

Australia

Facility Name

GSK Investigational Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

GSK Investigational Site

City

Epping

State/Province

Victoria

ZIP/Postal Code

3076

Country

Australia

Facility Name

GSK Investigational Site

City

Geelong

State/Province

Victoria

ZIP/Postal Code

3220

Country

Australia

Facility Name

GSK Investigational Site

City

Murdoch

State/Province

Western Australia

ZIP/Postal Code

6150

Country

Australia

Facility Name

GSK Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

GSK Investigational Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

GSK Investigational Site

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

GSK Investigational Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

GSK Investigational Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

GSK Investigational Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

GSK Investigational Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

GSK Investigational Site

City

Mechelen

ZIP/Postal Code

2800

Country

Belgium

Facility Name

GSK Investigational Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

GSK Investigational Site

City

Blagoevgrad

ZIP/Postal Code

2700

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Dimitrovgrad

ZIP/Postal Code

6400

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Pazardjik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1000

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1407

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1572

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3V 1Z2

Country

Canada

Facility Name

GSK Investigational Site

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

GSK Investigational Site

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8R 4R2

Country

Canada

Facility Name

GSK Investigational Site

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 1B2

Country

Canada

Facility Name

GSK Investigational Site

City

Scarborough

State/Province

Ontario

ZIP/Postal Code

M1E 5E9

Country

Canada

Facility Name

GSK Investigational Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E5J1

Country

Canada

Facility Name

GSK Investigational Site

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

Facility Name

GSK Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 1C8

Country

Canada

Facility Name

GSK Investigational Site

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

GSK Investigational Site

City

Temuco

State/Province

Región De La Araucania

Country

Chile

Facility Name

GSK Investigational Site

City

Concepción

State/Province

Región Del Biobio

ZIP/Postal Code

4070038

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8330024

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

GSK Investigational Site

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Ceske Budejovice

ZIP/Postal Code

370 01

Country

Czechia

Facility Name

GSK Investigational Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

GSK Investigational Site

City

Liberec

ZIP/Postal Code

460 63

Country

Czechia

Facility Name

GSK Investigational Site

City

Ostrava.

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

GSK Investigational Site

City

Pardubice

ZIP/Postal Code

523 03

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 10

ZIP/Postal Code

101 00

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

GSK Investigational Site

City

Praha 6

ZIP/Postal Code

169 02

Country

Czechia

Facility Name

GSK Investigational Site

City

Usti nad Labem

ZIP/Postal Code

401 13

Country

Czechia

Facility Name

GSK Investigational Site

City

Zlin

ZIP/Postal Code

762 75

Country

Czechia

Facility Name

GSK Investigational Site

City

Hellerup

ZIP/Postal Code

DK-2900

Country

Denmark

Facility Name

GSK Investigational Site

City

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Name

GSK Investigational Site

City

København NV

ZIP/Postal Code

DK-2400

Country

Denmark

Facility Name

GSK Investigational Site

City

København S

ZIP/Postal Code

DK-2300

Country

Denmark

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

10138

Country

Estonia

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Besançon Cedex

ZIP/Postal Code

25030

Country

France

Facility Name

GSK Investigational Site

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

GSK Investigational Site

City

Montauban cedex

ZIP/Postal Code

82017

Country

France

Facility Name

GSK Investigational Site

City

Nantes cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Paris Cedex 18

ZIP/Postal Code

75877

Country

France

Facility Name

GSK Investigational Site

City

Pau

ZIP/Postal Code

64000

Country

France

Facility Name

GSK Investigational Site

City

Strasbourg cedex

ZIP/Postal Code

67091

Country

France

Facility Name

GSK Investigational Site

City

Toulouse cedex 09

ZIP/Postal Code

31059

Country

France

Facility Name

GSK Investigational Site

City

Tourcoing cedex

ZIP/Postal Code

59208

Country

France

Facility Name

GSK Investigational Site

City

Valenciennes Cedex

ZIP/Postal Code

59322

Country

France

Facility Name

GSK Investigational Site

City

Bad Krozingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79189

Country

Germany

Facility Name

GSK Investigational Site

City

Esslingen

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

73730

Country

Germany

Facility Name

GSK Investigational Site

City

Freiburg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

GSK Investigational Site

City

Mannheim

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

68167

Country

Germany

Facility Name

GSK Investigational Site

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70376

Country

Germany

Facility Name

GSK Investigational Site

City

Bernau

State/Province

Brandenburg

ZIP/Postal Code

16321

Country

Germany

Facility Name

GSK Investigational Site

City

Bad Nauheim

State/Province

Hessen

ZIP/Postal Code

61231

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

65929

Country

Germany

Facility Name

GSK Investigational Site

City

Giessen

State/Province

Hessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

GSK Investigational Site

City

Kassel

State/Province

Hessen

ZIP/Postal Code

34121

Country

Germany

Facility Name

GSK Investigational Site

City

Langen

State/Province

Hessen

ZIP/Postal Code

63225

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

Facility Name

GSK Investigational Site

City

Aachen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

52074

Country

Germany

Facility Name

GSK Investigational Site

City

Bielefeld

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

33604

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53127

Country

Germany

Facility Name

GSK Investigational Site

City

Dortmund

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

44137

Country

Germany

Facility Name

GSK Investigational Site

City

Leverkusen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51375

Country

Germany

Facility Name

GSK Investigational Site

City

Moenchengladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41063

Country

Germany

Facility Name

GSK Investigational Site

City

Wuppertal

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42117

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04103

Country

Germany

Facility Name

GSK Investigational Site

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04289

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

22291

Country

Germany

Facility Name

GSK Investigational Site

City

Alexandroupolis

ZIP/Postal Code

68100

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 26

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 28

Country

Greece

Facility Name

GSK Investigational Site

City

Chalkida

ZIP/Postal Code

341 00

Country

Greece

Facility Name

GSK Investigational Site

City

N. Efkarpia, Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

570 10

Country

Greece

Facility Name

GSK Investigational Site

City

Chai Wan

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Kowloon

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Shatin, New Territories

Country

Hong Kong

Facility Name

GSK Investigational Site

City

Balatonfüred

ZIP/Postal Code

8230

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

GSK Investigational Site

City

Szolnok

ZIP/Postal Code

5004

Country

Hungary

Facility Name

GSK Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

GSK Investigational Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

GSK Investigational Site

City

Haddera

ZIP/Postal Code

38100

Country

Israel

Facility Name

GSK Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

GSK Investigational Site

City

Nahariya

ZIP/Postal Code

22100

Country

Israel

Facility Name

GSK Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

GSK Investigational Site

City

Parma

State/Province

Emilia-Romagna

ZIP/Postal Code

43100

Country

Italy

Facility Name

GSK Investigational Site

City

Udine

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

GSK Investigational Site

City

Bergamo

State/Province

Lombardia

ZIP/Postal Code

24127

Country

Italy

Facility Name

GSK Investigational Site

City

Cremona

State/Province

Lombardia

ZIP/Postal Code

26100

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20138

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20162

Country

Italy

Facility Name

GSK Investigational Site

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06156

Country

Italy

Facility Name

GSK Investigational Site

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Ganwon-do

ZIP/Postal Code

220-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Gwangju

ZIP/Postal Code

501-757

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

110-774

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

134-727

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

135-720

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

137-701

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

152-703

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44280

Country

Mexico

Facility Name

GSK Investigational Site

City

Queretaro

ZIP/Postal Code

76000

Country

Mexico

Facility Name

GSK Investigational Site

City

San Luis Potosi

ZIP/Postal Code

78240

Country

Mexico

Facility Name

GSK Investigational Site

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amersfoort

ZIP/Postal Code

3813 TZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1091 AC

Country

Netherlands

Facility Name

GSK Investigational Site

City

Delft

ZIP/Postal Code

2625 AD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Deventer

ZIP/Postal Code

7416 SE

Country

Netherlands

Facility Name

GSK Investigational Site

City

Helmond

ZIP/Postal Code

5707 HA

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nieuwegein

ZIP/Postal Code

3435 CM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Nijmegen

ZIP/Postal Code

6532 SZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Rotterdam

ZIP/Postal Code

3045 PM

Country

Netherlands

Facility Name

GSK Investigational Site

City

Schiedam

ZIP/Postal Code

3118 JH

Country

Netherlands

Facility Name

GSK Investigational Site

City

Sittard-geleen

ZIP/Postal Code

6162 BG

Country

Netherlands

Facility Name

GSK Investigational Site

City

Tilburg

ZIP/Postal Code

5042 AD

Country

Netherlands

Facility Name

GSK Investigational Site

City

Venlo

ZIP/Postal Code

5912 BL

Country

Netherlands

Facility Name

GSK Investigational Site

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

GSK Investigational Site

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

GSK Investigational Site

City

Grafton, Auckland

ZIP/Postal Code

1030

Country

New Zealand

Facility Name

GSK Investigational Site

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

GSK Investigational Site

City

New Plymouth

ZIP/Postal Code

4310

Country

New Zealand

Facility Name

GSK Investigational Site

City

Otahuhu, Auckland

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

GSK Investigational Site

City

Wellington South

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

GSK Investigational Site

City

Lillehammer

ZIP/Postal Code

2629

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

0407

Country

Norway

Facility Name

GSK Investigational Site

City

Skien

ZIP/Postal Code

N-3710

Country

Norway

Facility Name

GSK Investigational Site

City

Stavanger

ZIP/Postal Code

4011

Country

Norway

Facility Name

GSK Investigational Site

City

Tromsø

ZIP/Postal Code

9038

Country

Norway

Facility Name

GSK Investigational Site

City

Manila

ZIP/Postal Code

1000

Country

Philippines

Facility Name

GSK Investigational Site

City

Pasig City

ZIP/Postal Code

1600

Country

Philippines

Facility Name

GSK Investigational Site

City

Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

GSK Investigational Site

City

San Juan

ZIP/Postal Code

1500

Country

Philippines

Facility Name

GSK Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-094

Country

Poland

Facility Name

GSK Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

GSK Investigational Site

City

Gdynia

ZIP/Postal Code

81-348

Country

Poland

Facility Name

GSK Investigational Site

City

Inowroclaw

ZIP/Postal Code

88-100

Country

Poland

Facility Name

GSK Investigational Site

City

Krakow

ZIP/Postal Code

31-202

Country

Poland

Facility Name

GSK Investigational Site

City

Lubin

ZIP/Postal Code

59-301

Country

Poland

Facility Name

GSK Investigational Site

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

GSK Investigational Site

City

Olsztyn

ZIP/Postal Code

10-561

Country

Poland

Facility Name

GSK Investigational Site

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

GSK Investigational Site

City

Walbrzych

ZIP/Postal Code

58-309

Country

Poland

Facility Name

GSK Investigational Site

City

Warszawa

ZIP/Postal Code

04-073

Country

Poland

Facility Name

GSK Investigational Site

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

014461

Country

Romania

Facility Name

GSK Investigational Site

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

GSK Investigational Site

City

Craiova

ZIP/Postal Code

200642

Country

Romania

Facility Name

GSK Investigational Site

City

Barnaul

ZIP/Postal Code

656055

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Gatchina

ZIP/Postal Code

188300

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Irkutsk

ZIP/Postal Code

664049

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Kemerovo

ZIP/Postal Code

650002

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

111539

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

117292

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

121374

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

121552

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novosibirsk

ZIP/Postal Code

630008

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Perm

ZIP/Postal Code

614107

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ryazan

ZIP/Postal Code

390039

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Samara

ZIP/Postal Code

443070

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saratov

ZIP/Postal Code

410012

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St-Petersburg

ZIP/Postal Code

199106

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

190000

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

192242

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634012

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tyumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

833 48

Country

Slovakia

Facility Name

GSK Investigational Site

City

Kosice

ZIP/Postal Code

040 11

Country

Slovakia

Facility Name

GSK Investigational Site

City

Martin

ZIP/Postal Code

036 59

Country

Slovakia

Facility Name

GSK Investigational Site

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

GSK Investigational Site

City

Cape Town

ZIP/Postal Code

7505

Country

South Africa

Facility Name

GSK Investigational Site

City

Kuils River

ZIP/Postal Code

7580

Country

South Africa

Facility Name

GSK Investigational Site

City

Parktown West

ZIP/Postal Code

2193

Country

South Africa

Facility Name

GSK Investigational Site

City

Pinelands

ZIP/Postal Code

7405

Country

South Africa

Facility Name

GSK Investigational Site

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

GSK Investigational Site

City

Galdakano

ZIP/Postal Code

48960

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda (Madrid)

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Marid

ZIP/Postal Code

28040

Country

Spain

Facility Name

GSK Investigational Site

City

Santiago De Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

GSK Investigational Site

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

GSK Investigational Site

City

Göteborg

ZIP/Postal Code

SE-416 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Helsingborg

ZIP/Postal Code

SE-251 87

Country

Sweden

Facility Name

GSK Investigational Site

City

Jönköping

ZIP/Postal Code

SE-551 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-118 83

Country

Sweden

Facility Name

GSK Investigational Site

City

Västerås

ZIP/Postal Code

SE-721 89

Country

Sweden

Facility Name

GSK Investigational Site

City

Örebro

ZIP/Postal Code

SE-701 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Östersund

ZIP/Postal Code

SE-831 83

Country

Sweden

Facility Name

GSK Investigational Site

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

Facility Name

GSK Investigational Site

City

Hualien

ZIP/Postal Code

970

Country

Taiwan

Facility Name

GSK Investigational Site

City

Kaohsiung

ZIP/Postal Code

813

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei City

ZIP/Postal Code

104

Country

Taiwan

Facility Name

GSK Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

GSK Investigational Site

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

GSK Investigational Site

City

Chiangmai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

GSK Investigational Site

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

GSK Investigational Site

City

Ivano-Frankivsk

ZIP/Postal Code

76018

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kharkiv

ZIP/Postal Code

61018

Country

Ukraine

Facility Name

GSK Investigational Site

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

GSK Investigational Site

City

Lviv

ZIP/Postal Code

79015

Country

Ukraine

Facility Name

GSK Investigational Site

City

Uzhhorod

ZIP/Postal Code

88014

Country

Ukraine

Facility Name

GSK Investigational Site

City

Zaporizhzhya

ZIP/Postal Code

69000

Country

Ukraine

Facility Name

GSK Investigational Site

City

Basingstoke

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Edinburgh

ZIP/Postal Code

EH16 4SA

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Newcastle-upon-Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

York

ZIP/Postal Code

YO31 8HE

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

34508693

Citation

Cavender MA, O'Donoghue ML, Abbate A, Aylward P, Fox KA, Glaser RX, Park JG, Lopez-Sendon J, Steg PG, Sabatine MS, Morrow DA. Inhibition of p38 MAP kinase in patients with ST-elevation myocardial infarction - findings from the LATITUDE-TIMI 60 trial. Am Heart J. 2022 Jan;243:147-157. doi: 10.1016/j.ahj.2021.08.022. Epub 2021 Sep 8.

Results Reference

derived

PubMed Identifier

27043082

Citation

O'Donoghue ML, Glaser R, Cavender MA, Aylward PE, Bonaca MP, Budaj A, Davies RY, Dellborg M, Fox KA, Gutierrez JA, Hamm C, Kiss RG, Kovar F, Kuder JF, Im KA, Lepore JJ, Lopez-Sendon JL, Ophuis TO, Parkhomenko A, Shannon JB, Spinar J, Tanguay JF, Ruda M, Steg PG, Theroux P, Wiviott SD, Laws I, Sabatine MS, Morrow DA; LATITUDE-TIMI 60 Investigators. Effect of Losmapimod on Cardiovascular Outcomes in Patients Hospitalized With Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA. 2016 Apr 19;315(15):1591-9. doi: 10.1001/jama.2016.3609.

Results Reference

derived

PubMed Identifier

25965709

Citation

O'Donoghue ML, Glaser R, Aylward PE, Cavender MA, Crisp A, Fox KA, Laws I, Lopez-Sendon JL, Steg PG, Theroux P, Sabatine MS, Morrow DA. Rationale and design of the LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE trial. Am Heart J. 2015 May;169(5):622-630.e6. doi: 10.1016/j.ahj.2015.02.012. Epub 2015 Feb 23.

Results Reference

derived

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

116197

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

We'll reach out to this number within 24 hrs

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60) (LATITUDE)

Acute Coronary Syndrome

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