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NCT07409636Completed

A Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

A Retrospective, Observational Database Study to Assess the Real-World Effectiveness of Inclisiran and PCSK9 mAbs in Chinese Hypercholesterolemia Adult Patients

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

The purpose of this study was to describe the effectiveness of inclisiran and proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mAbs) in the real-world setting in China. Data for this study was obtained from three regional electronic health record (rEHR) databases and included patients who met the enrollment requirements during the study identification period (October 1, 2023 to June 30, 2024) who had used either inclisiran or PCSK9 mAb for the first time. The retrospective data up to the date of ethics committee (EC) approval was extracted from multiple rEHR databases to generate study-specific datasets supporting this study on respective secure data analysis platforms. Due to the requirements of data security policies, the patient-level data from rEHR databases could not be transferred out of the secure platform. Thus, independent analysis based on data from each of the three databases was performed separately and meta-analysis was conducted to integrate one result of all independent data analyses.

Status (registry)
Completed
Study type
Observational
Enrollment
11991 (actual)
First submitted
12 May 2025
Start date
23 Jan 2025
Primary completion date
22 Dec 2025
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT07409636

What you commit to

  • Study type: Observational
  • Participants enrolled: 11991
  • From 23 Jan 2025 to the primary completion date, 22 Dec 2025
  • 1 site in 1 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

  • In the inclisiran cohort, the first inclisiran injection was during the index period, and patients were treated with PCSK9 mAbs within 3 months prior to first inclisiran.

Other

  • Participated in any interventional or observational study of inclisiran or PCSK9 mAbs anytime during the study period.

Who the study is looking for

  • First received inclisiran or any PCSK9 mAbs during the indexing period.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis
Coordinator of this site? Confirm its status
East HanoverUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.