NCT07468500Not yet recruiting
Real World Adherence of PCSK9 Targeted Therapy
Real World Adherence of PCSK9 Targeted Therapy: A Retrospective Analysis of Japan Databases
Source: ClinicalTrials.gov · Last updated 20 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 3600 (estimated)
- First submitted
- 5 Mar 2026
- Start date
- 30 Mar 2026
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07468500
What you commit to
- Study type: Observational
- Planned participants: 3600
- From 30 Mar 2026 to the primary completion date, 30 Jul 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- At least one claim data for inclisiran or evolocumab 140 mg Pens within the 210 days prior to the index date (excluding the index date).
Other
- Those with any of the following criteria will be excluded.
- Both prescription records of inclisiran and evolocumab 140 mg Pens on the index date.
- At least one claim data for evolocumab 420 mg Auto mini-dosers during the observation period.
- Incomplete data for the one year (365 days) follow-up period due to loss to follow-up (the end of the observation period) or death. (only for adherence cohort).
Who the study is looking for
- The patients are included if they meet all the following criteria:
- At least one prescription of inclisiran or evolocumab (140 mg Pens) during the identification period.
- At least one diagnosis of dyslipidemia and/or hypercholesterolemia (familial and non-familial hypercholesterolemia) without suspicion flag during the look back period.
- At least 18 years on the index date.
- At least one claim record within the 210 days prior to the index date (excluding the index date).
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.