An observational study in Dyslipidemia, Hypercholesterolemia, sponsored by Novartis Pharmaceuticals. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
Retrospective observational cohort study to compare medication adherence at 12 months between patients in Japan with dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) who newly initiate inclisiran versus those who newly initiate evolocumab.
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's planned enrollment of 3,600 is above the median of 1,000 across 144 observational studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Compared within Hypercholesterolemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dyslipidemias. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Adult patients with dyslipidemia and/or hypercholesterolemia who initiated treatment with inclisiran or evolocumab in the period after first approval of inclisiran in 22-Nov-2023
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The patients are included if they meet all the following criteria:
Exclusion Criteria:
Those with any of the following criteria will be excluded.
patients who initiated inclisiran as their first treatment
patients who initiated evolocumab as their first treatment
Medication adherence at 12 months : proportion of days covered (PDC) within a period that the patient is persistent
Adherence is defined using proportion of days covered (PDC) within a period that the patient is persistent: calculated as the number of days covered by the target drug (inclisiran in the exposure group, evolocumab in the control group) during the 12 months follow-up period, divided by 365 days.
Time frame: 12 months
Proportion of patients with good adherence
Proportion of patients with good adherence at 12 months follow-up period, defined as PDC ≥ 80%.
Time frame: 12 months
Number of patients by demographic category
Time frame: Baseline
Time to discontinuation
The date of discontinuation of first treatment drug will be considered as the date of outcome occurrence.
Time frame: 12 months
Proportion of patients receiving LLTs
Proportion of patients receiving LLTs (statin only/ezetimibe only/statin and ezetimibe) during the baseline period and 12 months follow-up period
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Jul 2026, 4 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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