Adherence and Persistence to Inclisiran Among Early Users in Germany

May 12, 2023 updated by: Novartis Pharmaceuticals
The present study was a descriptive, non-interventional, retrospective cohort study aimed at evaluating early data on adherence, persistence, and treatment patterns among patients receiving inclisiran and other lipid-lowering therapies (LLT) in a real-world setting in Germany. Analysis was carried out using the IQVIA™ LRx database.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

Inclusion Criteria:

  • Study subjects ≥18 years old who were prescribed an inclisiran dose.

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Overall cohort
Patients receiving inclisiran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number and percentage of patients with at least 5 months of potential follow-up who were prescribed a second dose of inclisiran
Time Frame: 8 months
8 months
Percentage of patients who were prescribed a second dose of inclisiran between 1 and 6 months after prescription of first dose
Time Frame: 8 months
8 months
Median time between first and second prescribed doses
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Age and gender characteristics
Time Frame: 6 months
6 months
Age and gender distribution
Time Frame: 6 months
6 months
Prescriber specialty distribution for patients
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2022

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

May 12, 2022

Study Registration Dates

First Submitted

May 12, 2023

First Submitted That Met QC Criteria

May 12, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 12, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CKJX839A12013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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