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
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.
1 other identifier
interventional
3,503
33 countries
329
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2014
329 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2014
CompletedFirst Posted
Study publicly available on registry
May 23, 2014
CompletedStudy Start
First participant enrolled
June 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2015
CompletedResults Posted
Study results publicly available
June 2, 2017
CompletedJune 2, 2017
March 1, 2017
1.5 years
May 15, 2014
April 27, 2017
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Up to 12 weeks
Secondary Outcomes (25)
Number of Participants With First Occurrence of MACE Through Week 24
Up to Week 24
Number of Participants With First Occurrence of the Composite of CV Death or MI up to Week 12 and Week 24
Week 12 and Week 24
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.
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
Week 12, Week 24
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
Week 12, Week 24
- +20 more secondary outcomes
Study Arms (2)
Losmapimod
EXPERIMENTALLosmapimod 7.5 mg twice daily oral tablet
Placebo
PLACEBO COMPARATORPlacebo twice daily oral tablet
Interventions
Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.
Subjects will receive placebo as film-coated, round, plain faced tablets.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
- The TIMI Study Groupcollaborator
Study Sites (341)
GSK Investigational Site
Huntsville, Alabama, 35801, United States
GSK Investigational Site
Cottonwood, Arizona, 86326, United States
GSK Investigational Site
Tucson, Arizona, 85713, United States
GSK Investigational Site
Tucson, Arizona, 85724, United States
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Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Bakersfield, California, 93308, United States
GSK Investigational Site
Huntington Beach, California, 92648, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Monterey, California, 93940, United States
GSK Investigational Site
Orange, California, 92868, United States
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San Diego, California, 92161, United States
GSK Investigational Site
Torrance, California, 90509, United States
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Denver, Colorado, 80204, United States
GSK Investigational Site
Littleton, Colorado, 80120, United States
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Daytona Beach, Florida, 32117, United States
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Jacksonville, Florida, 32207, United States
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Jacksonville, Florida, 32209, United States
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Jacksonville Beach, Florida, 32250, United States
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Ocala, Florida, 34471, United States
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Pensacola, Florida, 32501, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33613, United States
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Vero Beach, Florida, 32960, United States
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Augusta, Georgia, 30901, United States
GSK Investigational Site
Rome, Georgia, 30165, United States
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Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Aurora, Illinois, 60504, United States
GSK Investigational Site
Elmhurst, Illinois, 60126, United States
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Indianapolis, Indiana, 46237, United States
GSK Investigational Site
Muncie, Indiana, 47303, United States
GSK Investigational Site
Iowa City, Iowa, 52240, United States
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West Des Moines, Iowa, 50266, United States
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Alexandria, Louisiana, 71301, United States
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Baton Rouge, Louisiana, 70809, United States
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Slidell, Louisiana, 70458, United States
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Zachary, Louisiana, 70791, United States
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Auburn, Maine, 04210, United States
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Boston, Massachusetts, 02115, United States
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Dearborn, Michigan, 48124, United States
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Grand Blanc, Michigan, 48439, United States
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Marquette, Michigan, 49855, United States
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Rochester, Michigan, 48307, United States
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Troy, Michigan, 48085, United States
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Ypsilanti, Michigan, 48197, United States
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Duluth, Minnesota, 55805, United States
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Minneapolis, Minnesota, 55407, United States
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Saint Paul, Minnesota, 55101, United States
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Kansas City, Missouri, 64114, United States
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Springfield, Missouri, 65804, United States
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St Louis, Missouri, 63110, United States
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Omaha, Nebraska, 68124, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
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Flemington, New Jersey, 08822, United States
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Ridgewood, New Jersey, 07450, United States
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Teaneck, New Jersey, 07666, United States
GSK Investigational Site
Voorhees Township, New Jersey, 08043, United States
GSK Investigational Site
Albany, New York, 12208, United States
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Poughkeepsie, New York, 12601, United States
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Stony Brook, New York, 11794, United States
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Charlotte, North Carolina, 28204, United States
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Greensboro, North Carolina, 27401, United States
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Raleigh, North Carolina, 27607, United States
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Raleigh, North Carolina, 27610, United States
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Canton, Ohio, 44710, United States
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Cleveland, Ohio, 44106, United States
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Columbus, Ohio, 45215, United States
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Mansfield, Ohio, 44906, United States
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Zanesville, Ohio, 43701, United States
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Oklahoma City, Oklahoma, 73135, United States
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Abington, Pennsylvania, 19001, United States
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Chambersburg, Pennsylvania, 17201, United States
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Danville, Pennsylvania, 17822-2160, United States
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Doylestown, Pennsylvania, 18901, United States
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Wilkes-Barre, Pennsylvania, 18702, United States
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York, Pennsylvania, 17403, United States
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Anderson, South Carolina, 29621, United States
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Rapid City, South Dakota, 57701, United States
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Chattanooga, Tennessee, 37404-1173, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37205, United States
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Austin, Texas, 78756, United States
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Dallas, Texas, 75216, United States
GSK Investigational Site
Round Rock, Texas, 78681, United States
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Victoria, Texas, 77901, United States
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Roanoke, Virginia, 24014, United States
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Tacoma, Washington, 98405, United States
GSK Investigational Site
Morgantown, West Virginia, 26506, United States
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Manitowoc, Wisconsin, 54220, United States
GSK Investigational Site
Wausau, Wisconsin, 54401, United States
GSK Investigational Site
Quilmes, Buenos Aires, B1878DFK, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2000DSR, Argentina
GSK Investigational Site
Venado Tuerto, Santa Fe Province, 2600, Argentina
GSK Investigational Site
Buenos Aires, C1428DCO, Argentina
GSK Investigational Site
Corrientes, W3400AMZ, Argentina
GSK Investigational Site
Santa Fe, S3000AZG, Argentina
GSK Investigational Site
Brisbane, Queensland, 4032, Australia
GSK Investigational Site
Cairns, Queensland, 4870, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Nambour, Queensland, 4560, Australia
GSK Investigational Site
Bedford Park, South Australia, 5042, Australia
GSK Investigational Site
Hobart, Tasmania, 7000, Australia
GSK Investigational Site
Epping, Victoria, 3076, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Murdoch, Western Australia, 6150, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Aalst, 9300, Belgium
GSK Investigational Site
Bonheiden, 2820, Belgium
GSK Investigational Site
Brasschaat, 2930, Belgium
GSK Investigational Site
Bruges, 8000, Belgium
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Leuven, 3000, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Mechelen, 2800, Belgium
GSK Investigational Site
Yvoir, 5530, Belgium
GSK Investigational Site
Blagoevgrad, 2700, Bulgaria
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Dimitrovgrad, 6400, Bulgaria
GSK Investigational Site
Pazardzhik, 4400, Bulgaria
GSK Investigational Site
Sofia, 1000, Bulgaria
GSK Investigational Site
Sofia, 1407, Bulgaria
GSK Investigational Site
Sofia, 1572, Bulgaria
GSK Investigational Site
Surrey, British Columbia, V3V 1Z2, Canada
GSK Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
GSK Investigational Site
Victoria, British Columbia, V8R 4R2, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E5J1, Canada
GSK Investigational Site
Kitchener, Ontario, N2M 1B2, Canada
GSK Investigational Site
Scarborough Village, Ontario, M1E 5E9, Canada
GSK Investigational Site
Thunder Bay, Ontario, P7B 6V4, Canada
GSK Investigational Site
Montreal, Quebec, H1T 1C8, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 5N4, Canada
GSK Investigational Site
Temuco, Región de La Araucania, Chile
GSK Investigational Site
Concepción, Región Del Biobio, 4070038, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8330024, Chile
GSK Investigational Site
Santiago, 8207257, Chile
GSK Investigational Site
Brno, 625 00, Czechia
GSK Investigational Site
České Budějovice, 370 01, Czechia
GSK Investigational Site
Hradec Králové, 500 05, Czechia
GSK Investigational Site
Liberec, 460 63, Czechia
GSK Investigational Site
Ostrava, 708 52, Czechia
GSK Investigational Site
Pardubice, 523 03, Czechia
GSK Investigational Site
Prague, 101 00, Czechia
GSK Investigational Site
Prague, 128 08, Czechia
GSK Investigational Site
Prague, 169 02, Czechia
GSK Investigational Site
Ústí nad Labem, 401 13, Czechia
GSK Investigational Site
Zlín, 762 75, Czechia
GSK Investigational Site
Hellerup, DK-2900, Denmark
GSK Investigational Site
Hvidovre, 2650, Denmark
GSK Investigational Site
København NV, DK-2400, Denmark
GSK Investigational Site
København S, DK-2300, Denmark
GSK Investigational Site
Tallinn, 10138, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Besançon, 25030, France
GSK Investigational Site
Dijon, 21079, France
GSK Investigational Site
Montauban, 82017, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75877, France
GSK Investigational Site
Pau, 64000, France
GSK Investigational Site
Strasbourg, 67091, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Tourcoing, 59208, France
GSK Investigational Site
Valenciennes, 59322, France
GSK Investigational Site
Bad Krozingen, Baden-Wurttemberg, 79189, Germany
GSK Investigational Site
Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70376, Germany
GSK Investigational Site
Bernau bei Berlin, Brandenburg, 16321, Germany
GSK Investigational Site
Bad Nauheim, Hesse, 61231, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 65929, Germany
GSK Investigational Site
Giessen, Hesse, 35392, Germany
GSK Investigational Site
Kassel, Hesse, 34121, Germany
GSK Investigational Site
Langen, Hesse, 63225, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Aachen, North Rhine-Westphalia, 52074, Germany
GSK Investigational Site
Bielefeld, North Rhine-Westphalia, 33604, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53127, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44137, Germany
GSK Investigational Site
Leverkusen, North Rhine-Westphalia, 51375, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41063, Germany
GSK Investigational Site
Wuppertal, North Rhine-Westphalia, 42117, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Leipzig, Saxony, 04289, Germany
GSK Investigational Site
Hamburg, 20099, Germany
GSK Investigational Site
Hamburg, 20246, Germany
GSK Investigational Site
Hamburg, 22291, Germany
GSK Investigational Site
Alexandroupoli, 68100, Greece
GSK Investigational Site
Athens, 115 26, Greece
GSK Investigational Site
Athens, 115 28, Greece
GSK Investigational Site
Chalcis, 341 00, Greece
GSK Investigational Site
N. Efkarpia, Thessaloniki, 56429, Greece
GSK Investigational Site
Thessaloniki, 570 10, Greece
GSK Investigational Site
Chai Wan, Hong Kong
GSK Investigational Site
Kowloon, Hong Kong
GSK Investigational Site
Shatin, New Territories, Hong Kong
GSK Investigational Site
Balatonfüred, 8230, Hungary
GSK Investigational Site
Budapest, 1122, Hungary
GSK Investigational Site
Budapest, 1134, Hungary
GSK Investigational Site
Szolnok, 5004, Hungary
GSK Investigational Site
Zalaegerszeg, 8900, Hungary
GSK Investigational Site
Ashkelon, 78278, Israel
GSK Investigational Site
Haddera, 38100, Israel
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Nahariya, 22100, Israel
GSK Investigational Site
Tel Aviv, 64239, Israel
GSK Investigational Site
Parma, Emilia-Romagna, 43100, Italy
GSK Investigational Site
Udine, Friuli Venezia Giulia, 33100, Italy
GSK Investigational Site
Bergamo, Lombardy, 24127, Italy
GSK Investigational Site
Cremona, Lombardy, 26100, Italy
GSK Investigational Site
Milan, Lombardy, 20138, Italy
GSK Investigational Site
Milan, Lombardy, 20162, Italy
GSK Investigational Site
Perugia, Umbria, 06156, Italy
GSK Investigational Site
Guadalajara, Jalisco, 44280, Mexico
GSK Investigational Site
Querétaro, 76000, Mexico
GSK Investigational Site
San Luis Potosí City, 78240, Mexico
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Amersfoort, 3813 TZ, Netherlands
GSK Investigational Site
Amsterdam, 1091 AC, Netherlands
GSK Investigational Site
Delft, 2625 AD, Netherlands
GSK Investigational Site
Deventer, 7416 SE, Netherlands
GSK Investigational Site
Helmond, 5707 HA, Netherlands
GSK Investigational Site
Nieuwegein, 3435 CM, Netherlands
GSK Investigational Site
Nijmegen, 6532 SZ, Netherlands
GSK Investigational Site
Rotterdam, 3045 PM, Netherlands
GSK Investigational Site
Schiedam, 3118 JH, Netherlands
GSK Investigational Site
Sittard-geleen, 6162 BG, Netherlands
GSK Investigational Site
Tilburg, 5042 AD, Netherlands
GSK Investigational Site
Venlo, 5912 BL, Netherlands
GSK Investigational Site
Zwolle, 8025 AB, Netherlands
GSK Investigational Site
Christchurch, 8011, New Zealand
GSK Investigational Site
Grafton, Auckland, 1030, New Zealand
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Hamilton, 3204, New Zealand
GSK Investigational Site
New Plymouth, 4310, New Zealand
GSK Investigational Site
Otahuhu, Auckland, 1640, New Zealand
GSK Investigational Site
Wellington South, 6021, New Zealand
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Lillehammer, 2629, Norway
GSK Investigational Site
Oslo, 0407, Norway
GSK Investigational Site
Skien, N-3710, Norway
GSK Investigational Site
Stavanger, 4011, Norway
GSK Investigational Site
Tromsø, 9038, Norway
GSK Investigational Site
Manila, 1000, Philippines
GSK Investigational Site
Pasig, 1600, Philippines
GSK Investigational Site
Quezon City, 1100, Philippines
GSK Investigational Site
San Juan City, 1500, Philippines
GSK Investigational Site
Bydgoszcz, 85-094, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-348, Poland
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Inowrocław, 88-100, Poland
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Krakow, 31-202, Poland
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Lubin, 59-301, Poland
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Lublin, 20-954, Poland
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Olsztyn, 10-561, Poland
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Torun, 87-100, Poland
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Warsaw, 04-073, Poland
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Wałbrzych, 58-309, Poland
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Wroclaw, 50-556, Poland
GSK Investigational Site
Bucharest, 014461, Romania
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Bucharest, 050098, Romania
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Craiova, 200642, Romania
GSK Investigational Site
Barnaul, 656055, Russia
GSK Investigational Site
Gatchina, 188300, Russia
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Irkutsk, 664049, Russia
GSK Investigational Site
Kemerovo, 650002, Russia
GSK Investigational Site
Moscow, 111539, Russia
GSK Investigational Site
Moscow, 117292, Russia
GSK Investigational Site
Moscow, 121374, Russia
GSK Investigational Site
Moscow, 121552, Russia
GSK Investigational Site
Novosibirsk, 630008, Russia
GSK Investigational Site
Perm, 614107, Russia
GSK Investigational Site
Ryazan, 390026, Russia
GSK Investigational Site
Ryazan, 390039, Russia
GSK Investigational Site
Saint Petersburg, 190000, Russia
GSK Investigational Site
Saint Petersburg, 192242, Russia
GSK Investigational Site
Saint Petersburg, 199106, Russia
GSK Investigational Site
Samara, 443070, Russia
GSK Investigational Site
Saratov, 410012, Russia
GSK Investigational Site
Saratov, 410028, Russia
GSK Investigational Site
Tomsk, 634012, Russia
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Tyumen, 625023, Russia
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Bratislava, 833 48, Slovakia
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Košice, 040 11, Slovakia
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Martin, 036 59, Slovakia
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Nitra, 949 01, Slovakia
GSK Investigational Site
Bellville, 7530, South Africa
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Cape Town, 7505, South Africa
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Kuils River, 7580, South Africa
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Parktown West, 2193, South Africa
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Pinelands, 7405, South Africa
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Somerset West, 7130, South Africa
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Daejeon, 301-721, South Korea
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Ganwon-do, 220-701, South Korea
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Gwangju, 501-757, South Korea
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Seoul, 110-774, South Korea
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Seoul, 134-727, South Korea
GSK Investigational Site
Seoul, 135-720, South Korea
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Seoul, 137-701, South Korea
GSK Investigational Site
Seoul, 152-703, South Korea
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Barcelona, 08907, Spain
GSK Investigational Site
Galdakano, 48960, Spain
GSK Investigational Site
Madrid, 28007, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda (Madrid), 28222, Spain
GSK Investigational Site
Marid, 28040, Spain
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Málaga, 29010, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Seville, 41071, Spain
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Gothenburg, SE-416 85, Sweden
GSK Investigational Site
Helsingborg, SE-251 87, Sweden
GSK Investigational Site
Jönköping, SE-551 85, Sweden
GSK Investigational Site
Örebro, SE-701 85, Sweden
GSK Investigational Site
Östersund, SE-831 83, Sweden
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Stockholm, SE-118 83, Sweden
GSK Investigational Site
Västerås, SE-721 89, Sweden
GSK Investigational Site
Changhua, 500, Taiwan
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Hualien City, 970, Taiwan
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Kaohsiung City, 813, Taiwan
GSK Investigational Site
Taipei, 104, Taiwan
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Taipei, 112, Taiwan
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Bangkok, 10700, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
GSK Investigational Site
Cherkassy, 18009, Ukraine
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Ivano-Frankivsk, 76018, Ukraine
GSK Investigational Site
Kharkiv, 61018, Ukraine
GSK Investigational Site
Kyiv, 03680, Ukraine
GSK Investigational Site
Lviv, 79015, Ukraine
GSK Investigational Site
Uzhhorod, 88014, Ukraine
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Zaporizhzhya, 69000, Ukraine
GSK Investigational Site
Basingstoke, RG24 9NA, United Kingdom
GSK Investigational Site
Bournemouth, BH7 7DW, United Kingdom
GSK Investigational Site
Dundee, DD1 9SY, United Kingdom
GSK Investigational Site
Edinburgh, EH16 4SA, United Kingdom
GSK Investigational Site
Newcastle upon Tyne, NE7 7DN, United Kingdom
GSK Investigational Site
York, YO31 8HE, United Kingdom
Related Publications (3)
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.
PMID: 34508693DERIVEDO'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.
PMID: 27043082DERIVEDO'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.
PMID: 25965709DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2014
First Posted
May 23, 2014
Study Start
June 3, 2014
Primary Completion
December 14, 2015
Study Completion
December 14, 2015
Last Updated
June 2, 2017
Results First Posted
June 2, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.