Hypercholesterolemia MedDRA version: 20.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Inclisiran for Injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INCLISIRAN
CAS Number: 1639324-58-5
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 Phase III lipid-lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10) MDCO-PCS-17-08 (ORION-11), or MDCO-PCS 17-02 (ORION-5)], 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 procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1700 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000
Exclusion criteria
Exclusion criteria: 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 study e.Persons directly involved in the conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are to evaluate: -The effect of inclisiran treatment on the proportion of subjects achieving prespecified low density lipoprotein cholesterol (LDL-C) targets at end of study (EOS) -The safety and tolerability profile of long term use of inclisiran ; Secondary Objective: Secondary: The secondary objectives are to evaluate the effect of inclisiran on: -LDL-C levels -Other lipids and lipoproteins ;Primary end point(s): Proportion of subjects who attain global lipid targets (entry criterion from respective previous study) for their level of ASCVD risk at End of Study;Timepoint(s) of evaluation of this end point: End of Study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Absolute change and percentage change in LDL-C from baseline (defined as baseline in feeder study) to End of Study -Absolute change and percentage change in other lipids and lipoprotein from baseline (defined as baseline in feeder study) to End of Study ;Timepoint(s) of evaluation of this end point: from baseline (defined as baseline in feeder study) to End of Study | — |
Countries
Canada, Czech Republic, Denmark, Germany, Hong Kong, Hungary, Israel, Netherlands, Oman, Poland, Russian Federation, Serbia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Health Science Center
The Medicines Company
Outcome results
None listed