NL-OMON41191已完成3 期
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, LATITUDE STUDY) (Short title: LosmApimod To Inhibit p38 MAP kinase as a TherapeUtic target and moDify outcomes after an acute coronary syndromE (LATITUDE)-TIMI 60) - PM1116197 (LATITUDE)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 870
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Patients 35 years and above.
- •* Hospitalization for NSTEMI or STEMI (see protocol page 30-31 for details).
- •* At least one of the predictors of cardiovascular disease (see protocol page 31 for details).
排除标准
- •* Unable to be randomized prior to coronary revascularization or fibrinolysis for the qualifying MI.
- •* Severe heart failure or shock (New York Heart Association [NYHA] class III or IV, or Killip class III or IV).
- •* Ongoing clinical instability (see protocol page 32 for details).
- •* History of chronic liver disease or severe renal impairment (see protocol page 32 for details).
- •* Known active tuberculosis, HIV, active opportunistic or other active life threatening infections.
- •* Vaccination with a live attenuated vaccine within 6 weeks of randomization.
- •* Pregnancy, lactation.
- •* Use of another investigational product (see protocol page 33 for details).
研究者
相似试验
进行中（未招募）
不适用
PM1116197 is a Clinical Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to PlaceboEUCTR2013-000657-50-HUGlaxoSmithKline Research & Development Ltd25,500
进行中（未招募）
1 期
PM1116197 is a Clinical Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to PlaceboMedDRA version: 18.0Level: LLTClassification code 10003723Term: Attack coronarySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 18.0Level: LLTClassification code 10041894Term: ST segment elevationSystem Organ Class: 100000004848EUCTR2013-000657-50-DEGlaxoSmithKline Research & Development Ltd25,500
进行中（未招募）
1 期
PM1116197 is a Clinical Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to PlaceboSubjects with ACS on the time to first occurrence of adjudicated MACE (defined as CV death, MI, or severe recurrent ischemia [SRI-UR])MedDRA version: 17.1Level: LLTClassification code 10003723Term: Attack coronarySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 17.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 17.1Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 17.1Level: LLTClassification code 10041894Term: ST segment elevationSystem Organ Class: 100000004848EUCTR2013-000657-50-ROGlaxoSmithKline Research & Development Ltd3,489
进行中（未招募）
不适用
PM1116197 is a Clinical Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to PlaceboSubjects with ACS on the time to first occurrence of adjudicated MACE (defined as CV death, MI, or severe recurrent ischemia [SRI-UR])MedDRA version: 17.0Level: LLTClassification code 10003723Term: Attack coronarySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 17.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 17.0Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 17.0Level: LLTClassification code 10041894Term: ST segment elevationSystem Organ Class: 100000004848EUCTR2013-000657-50-GRGlaxoSmithKline Research & Development Ltd25,500
进行中（未招募）
1 期
PM1116197 is a Clinical Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting with Acute Coronary Syndrome Treated with Losmapimod Compared to PlaceboMedDRA version: 16.1Level: LLTClassification code 10003723Term: Attack coronarySystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 16.1Level: LLTClassification code 10041894Term: ST segment elevationSystem Organ Class: 100000004848EUCTR2013-000657-50-SEGlaxoSmithKline Research & Development Ltd25,500