Phase
Condition
Hypercholesterolemia
Familial Hypercholesterolemia
Treatment
Inclisiran
Clinical Study ID
Ages 18-105 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Inclisiran Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia
Age ≥ 18 years at baseline
Initiated treatment with inclisiran according to the decision of both physician andpatient
Signed informed consent(s) must be obtained prior to participation in the study
SoC Historical Cohort Patients eligible for inclusion in this study must meet all of the following criteria.
Confirmed diagnosis of primary hypercholesterolemia or mixed dyslipidemia, withwhich reference to LDL-C > 70 mg/dL (1.8 mmol/L)
Age ≥ 18 years
Compliance with the standard lipid-lowering therapy, which is defined as a changefrom prior lipid-lowering therapy to an optimal lipid-lowering regimen, with thedate of compliance with standard lipid-lowering therapy after January 1, 2017 as theindex date
With available LDL-C test at baseline, which is defined as the closest LDL-C test tothe index date within 6 months prior to the index date
With available LDL-C test on D90 (90±60 days) or D330 (330±90 days) after the indexdate
Exclusion
Exclusion Criteria:
Inclisiran Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.
Treatment with monoclonal antibodies directed towards PCSK9 within 90 days beforefirst visit (V1)
Severe hepatic impairment (Child-Pugh class C)
Severe renal impairment (eGFR ≤ 30 mL/min), and/or on hemodialysis
Participation in any cardiovascular clinical trial, concurrent or within the last 30days of the baseline
Females who are pregnant or nursing, or who are preparing for pregnancy
Hypersensitivity to the active substance or to any of the excipients of inclisiransolution
SoC Historical Cohort Patients meeting any of the following criteria are not eligible for inclusion in this study.
Treatment with monoclonal antibodies directed towards PCSK9 during research period
Severe hepatic impairment (Child-Pugh class C)
Severe renal impairment, (eGFR ≤ 30 mL/min), and/or on hemodialysis
Participation in any cardiovascular clinical trial during research period
Females who are pregnant or nursing during research period
Study Design
Study Description
Connect with a study center
Novartis Investigative Site
Haikou, Hainan 570208
ChinaSite Not Available
Novartis Investigative Site
Qionghai, Hainan 571437
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.