NL-OMON55497已完成3 期
A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8) - MDCO-PCS-17-05 (CKJX839A12306B) (ORION-8)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 152
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
- •Subjects may be included if they meet all of the following inclusion criteria
- •prior to entry into this study: 1.Completion of a previously qualifying
- •inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid-lowering
- •ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10)
- •MDCO-PCS-17-08 or (ORION-11),], meaning the subject received the last dose of
- •study drug and completed the final study visit per applicable protocol. 2.On
- •current lipid-lowering therapies (such as a statin and/or ezetimibe) from
- •previous study with no planned medication or dose change during study
- •participation. 3.Willing and able to give informed consent before initiation of
- •any study-related procedures and willing to comply with all required study
排除标准
- •Subjects will be excluded from the study if any of the following exclusion
- •criteria apply immediately prior to entry into the study:
- •1.Any uncontrolled or serious disease, or any medical or surgical condition,
- •that may either interfere with participation in the clinical study, and/or put
- •the subject at significant risk (according to investigator*s [or delegate*s]
- •judgment) if he/she participates in the clinical study.
- •2.An underlying known disease, or surgical, physical, or medical condition
- •that, in the opinion of the investigator (or delegate) might interfere with
- •interpretation of the clinical study results.
- •3.Severe concomitant noncardiovascular disease that carries the risk of
- •reducing life expectancy to less than 3 years.
- •4.Active liver disease defined as any known current infectious, neoplastic, or
- •metabolic pathology of the liver or unexplained elevations in alanine
- •aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit
- •of normal (ULN), or total bilirubin (TBIL) elevation >2x ULN at last recorded
- •visit in the feeder study prior to study entry visit.
- •5.Females who are pregnant or nursing, or who are of childbearing potential and
- •unwilling to use at least one method of acceptable effective contraception (eg,
- •oral contraceptives, barrier methods, approved contraceptive implant, long-term
- •injectable contraception, intrauterine device) for the entire duration of the
- •study. Exemptions from this criterion:
- •a.Women >2 years postmenopausal (defined as 1 year or longer since their last
- •menstrual period) AND more than 55 years of age
- •b.Postmenopausal women (as defined above) and less than 55 years old with a
- •negative pregnancy test within 24 hours of enrollment
- •c.Women who are surgically sterilized at least 3 months prior to enrollment
- •6.Planned use of other investigational medicinal products other than inclisiran
- •or devices during the course of the study.
- •7.Any condition that according to the investigator could interfere with the
- •conduct of the study, such as but not limited to:
- •a.Subjects who are unable to communicate or to cooperate with the investigator
- •b.Unable to understand the protocol requirements, instructions and
- •study-related restrictions, the nature, scope, and possible consequences of the
- •study (including subjects whose cooperation is doubtful due to drug abuse or
- •alcohol dependency)
- •c.Unlikely to comply with the protocol requirements, instructions, and
- •study-related restrictions (eg, uncooperative attitude, inability to return for
- •follow-up visits, and improbability of completing the study)
- •d.Have any medical or surgical condition, which in the opinion of the
- •investigator would put the subject at increased risk from participating in the
- •e.Persons directly involved in the conduct of the study
研究者
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