NCT06595069Completed
A Real-world Study to Assess the Characteristics and Long-term Effectiveness of Inclisiran in Chinese Adult Patients
A Single-Center, Retrospective, Observational Study to Assess the Characteristics and the Real-World Long-Term Effectiveness of Inclisiran in Chinese Adult Patients
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
This was a single-center, retrospective, observational study (non-interventional study with secondary use of data) among patients in a real-world setting. This study used the medical record data from patients in Yiling. Eligible patients who newly initiated inclisiran from 26 January 2022 to 21 August 2023 were included. The retrospective data up to the date of ethics committee approval (April 2024) was collected. The study team collected patient data using an electronic case report form (eCRF) from April 2024 to June 2024.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 600 (actual)
- First submitted
- 10 Sept 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 10 Jul 2024
- Lead sponsor
- Novartis
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT06595069
What you commit to
- Study type: Observational
- Participants enrolled: 600
- From 30 Apr 2024 to the primary completion date, 10 Jul 2024
- 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.
Other
- Participated in any blinded interventional clinical studies anytime during the study period.
Who the study is looking for
- Received at least one inclisiran injection during the indexing period.
- Had at least 9 months of follow-up from the index date (had at least one LDL-C assessment during baseline period and at least one LDL-C assessment at 9 months or later).
- Patients signed the informed consent form.
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.