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
- Diseases
- Familial hypercholesterolaemia
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.