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NCT02145468 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,503
- Enrollment target
NCT02145468: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02145468 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 3,503 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (354% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02145468, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,503 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo twice daily
- DRUG Standard therapy
- DRUG Losmapimod 7.5 mg twice daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,503 participants |
| Start Date | 2014-06-03 |
| Est. Completion | 2015-12-14 |
| Phase | Phase 3 |
What the finished NCT02145468 record still lists
NCT02145468 is an interventional study that assigns participants to a tested intervention. Its 3,503 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (354% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo twice daily is the first listed.
NCT02145468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02145468 about?
NCT02145468 is a clinical study titled "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)". 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. ...
What is the current status of trial NCT02145468?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,503 participants. The study started on 2014-06-03. Estimated completion is 2015-12-14.
What interventions are being tested in trial NCT02145468?
The interventions under investigation include: Placebo twice daily (DRUG), Standard therapy (DRUG), Losmapimod 7.5 mg twice daily (DRUG).
Who is sponsoring clinical trial NCT02145468?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02145468's enrollment target sits among peer trials
3,503 68th of 2000 higher than 1,933 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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