JPRN-jRCT2071230064招募中3 期
A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
Tanaka Yoshiyuki0 个研究点目标入组 280 人开始时间: 2023年9月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 280
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Meets one of the following:
- •1. Age >= 18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: >= 30 days post MI (presumed Type 1 due to plaque rupture or erosion); >= 30 days post ischemic stroke (presumed due to atherosclerosis); or >= 30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or
- •2. High risk for first major ASCVD event defined as at least 1 of the following: Age >= 50 years with evidence of coronary artery disease; Age >= 50 years with evidence of atherosclerotic cerebrovascular disease; Age >= 50 years with evidence of peripheral arterial disease; or Age >= 60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio >= 30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for >= 10 years
- •- Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows:
- •1. History of major ASCVD Event: LDL-C >= 70 mg/dL (1.81 mmol/L) OR non-HDL-C >= 100 mg/dL (2.59 mmol/L)
- •2. High risk for first major ASCVD Event: LDL-C >= 90 mg/dL (2.33 mmol/L) OR non-HDL-C >= 120 mg/dL (3.11 mmol/L)
- •- Is treated with moderate- or high-intensity statin (+- nonstatin lipid-lowering therapy [LLT]) at Visit 1
- •- Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study
排除标准
- •- Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
- •- Has New York Heart Association Class 4 heart failure, last known Left Ventricular Ejection Fraction =<25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening)
- •- Has recurrent ventricular tachycardia within 3 months prior to randomization
- •- Has a planned arterial revascularization procedure
- •- Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program
- •- Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout.
- •- Has a fasting triglyceride value >=400 mg/dL (>=4.52 mmol/L) at Visit 1 (Screening)
- •- Has history of severe renal insufficiency defined as estimated glomerular filtration rate <30 mL/min/1.73 m2 at Visit 1 (Screening) or has end-stage renal disease on dialysis.
研究者
相似试验
招募中
1 期
A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular RiskASCVD - Atherosclerotic Cardiovascular DiseaseMedDRA version: 20.0Level: LLTClassification code: 10057079Term: Heterozygous familial hypercholesterolemia Class: 10010331CTIS2022-502781-24-01Merck Sharp & Dohme LLC14,335
进行中（未招募）
1 期
A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular RiskASCVD - Atherosclerotic Cardiovascular DiseaseMedDRA version: 20.0Level: LLTClassification code: 10057079Term: Heterozygous familial hypercholesterolemia Class: 10010331CTIS2022-502781-24-00Merck Sharp & Dohme LLC10,855
尚未招募
3 期
MK-0616 Cardiovascular Outcomes StudyE780 Pure hypercholesterolaemiaPure hypercholesterolaemiaE780PER-031-23Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)
进行中（未招募）
1 期
Phase 3 study of SBRT ± pembrolizumab for participants with medically inoperable Stage I or IIA NSCLCEUCTR2018-004320-11-GBMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.530
进行中（未招募）
1 期
Phase 3 study of SBRT ± pembrolizumab for participants with medically inoperable Stage I or IIA NSCLCon-Small Cell Lung Cancer Stage I or IIAMedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004320-11-ESMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.530