Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and El… (NCT03814187) | Clinical Trial Compass
CompletedPhase 3
Trial to Assess the Effect of Long Term Dosing of Inclisiran in Subjects With High CV Risk and Elevated LDL-C
United States3,275 participantsStarted 2019-04-16
Plain-language summary
The purpose of this extension study was to evaluate the efficacy, safety, and tolerability of long-term dosing of Inclisiran. The study was a global multicenter study.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Completion on a previously qualifying inclisiran Phase II trial MDCO-PCS-16-01 (ORION-3), or Phase III lipid lowering ORION feeder study \[MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-4 (ORION-10), or MDCO-PCS-17-08 (ORION-11)\] meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
✓. 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.
✓. Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures.
Exclusion criteria
✕. 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.
✕. 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.
✕. Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years,
✕. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST), elevation \>3x the upper limit of normal (ULN), or total bilirubin (TBIL) elevation \>2x ULN at the last recorded visit in the feeder study prior to study entry visit.
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What they're measuring
1
Proportion of Subjects Achieving Global Lipid Targets for Their Level of ASCVD Risk
Timeframe: From ORION-8 Day 1 to the end of study (up to 1080 days)
2
Incidence of Treatment-emergent Adverse Events (TEAEs)
Timeframe: From ORION-8 Day 1 to the end of study (up to 1080 days)
. 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:
✕. Women \>2 years postmenopausal (defined as 1 year or longer since last menstrual period) and more than 55 years of age.
✕. Postmenopausal women (as defined above) and less than 55 years of age with a negative pregnancy test within 24 hours of randomization.
✕. Women who are surgically sterilized at least 3 months prior to enrollment.