PER-085-20招募中未知
A RANDOMIZED DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER TRIAL ASSESSING THE IMPACT OF LIPOPROTEIN (A) LOWERING WITH TQJ230 ON MAJOR CARDIOVASCULAR EVENTS IN PATIENTS WITH ESTABLISHED CARDIOVASCULAR DISEASE
ovartis Pharma AG.,0 个研究点目标入组 0 人开始时间: 2021年1月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
入选标准
- •1. Written informed consent.
- •2. Male and female 18 to ≤ 80 years of age.
- •3. Lp(a) ≥ 70 mg/dL at the screening visit.
- •4. LDL-cholesterol lowering treatment at Randomization.
- •5. Subjects must be optimally treated for other CV risk factors according to local practice/guidelines.
- •6. Established CV disease.
排除标准
- •1. Uncontrolled hypertension.
- •2. Treatment with niacin .
- •3. Treatment with stable dose of a PCSK9 inhibitor.
- •4. Treatment with lipoprotein apheresis.
- •5. Within 3 months of screening: myocardial infarction, stroke, coronary or lower limb re-vascularization, major cardiac or non-cardiac surgery.
- •6. Cardiac, cerebrovascular or peripheral artery surgery or coronary revascularization after D1.
- •7. NYHA class IV.
- •8. Hemorrhagic stroke.
- •9. Severe concomitant non-CV disease.
- •10. Severe infection or hematologic, metabolic, gastrointestinal or endocrine dysfunction.
- •11. Malignancy of any organ system.
- •12. Lab analyses within limits.
- •13. Positive HIV, Hepatitis C or Hepatitis B.
- •14.Treatment with an oligonucleotide or SiRNA.
- •15.Hypersensitivity to the study drug.
- •16. Use of other investigational drugs.
- •17.Pregnant or nursing women.
- •18.Women of child-bearing potential unless using highly effective methods of contraception.
研究者
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