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
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
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Basel, Switzerland
- Novartis
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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 |
|---|
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Overall cohort
Patients receiving inclisiran
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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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
|
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Age and gender distribution
Time Frame: 6 months
|
6 months
|
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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
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.