High Levels of Low-density Lipoprotein CholesterolNCT05870657
Adherence and Persistence to Inclisiran Among Early Users in Germany
An observational study of High Levels of Low-density Lipoprotein Cholesterol, run by Novartis Pharmaceuticals at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Levels of Low-density Lipoprotein Cholesterol
- How many people
- 1,109 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Feb 2022to 12 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study
Who may be able to join
- Study subjects ≥18 years old who were prescribed an inclisiran dose.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overall cohort | Patients receiving inclisiran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients with at least 5 months of potential follow-up who were prescribed a second dose of inclisiran
Measured: 8 months
Percentage of patients who were prescribed a second dose of inclisiran between 1 and 6 months after prescription of first dose
Measured: 8 months
Median time between first and second prescribed doses
Measured: 8 months
Secondary outcomes (3)
Age and gender characteristics
Measured: 6 months
Age and gender distribution
Measured: 6 months
Prescriber specialty distribution for patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start16 Feb 2022
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Levels of Low-density Lipoprotein CholesterolStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870657
- Sponsor's protocol ID
- CKJX839A12013
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Persistence to Inclisiran Among Early Users in Germany
- ClinicalTrials.gov ID
- NCT05870657
- Acronym / sponsor ID
- CKJX839A12013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,109 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall cohort | – | –Patients receiving inclisiran |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study
Key inclusion criteria (1 listed)
- Study subjects ≥18 years old who were prescribed an inclisiran dose.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Median time between first and second prescribed doses
Time frame: 8 months
3 secondary outcomes
Age and gender characteristics
Time frame: 6 months
Age and gender distribution
Time frame: 6 months
Prescriber specialty distribution for patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Levels of Low-density Lipoprotein Cholesterol, run by Novartis Pharmaceuticals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.