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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07409636
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jan 23, 2025
Status verified
Feb 2026
Primary completion
Dec 22, 2025
Completion
Dec 22, 2025

Study Design

Enrollment
11,991 participants (actual)

Arms

  • Arm: Inclisiran Cohort
    Adult patients who first received inclisiran between 01 October 2023 and 30 June 2024.
  • Arm: PCSK9 mAbs Cohort
    Adult patients who first received PCSK9 mAbs between 01 October 2023 and 30 June 2024.

Primary Outcome Measure

Percentage Change in Low Density Lipoprotein Cholesterol (LDL-C) From Baseline [ Time Frame: From Baseline to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
NovartisEast HanoverNew Jersey07936-

Find similar trials in East Hanover, NJ

By research site
Novartis· East Hanover, NJ

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