HypercholesterolemiaGINNCT05438069
German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany
An observational study of Hypercholesterolemia, run by Jena University Hospital at 1 site in Germany.
Trial summary
The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 11 Dec 2020to 11 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: -patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran
Who may be able to join
- patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
- patients 18 years and older
Who cannot join
- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Jena University Hospital
Jena
Oliver Weingärtner, MD, +4936419324521, oliver.weingaertner@med.uni-jena.de
Martin Foerster, PhD, +4936419325818, Martin.Foerster@med.uni-jena.de
About this study
The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany
Read the detailed description
The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.
- Conditions
- Hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
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 |
|---|---|---|
| Patients with elevated LDL-cholesterol (hypercholesterolemia) | Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C change
LDL-C change in mg/dL / mmol/L
Measured: 3 months, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start11 Dec 2020
- Primary completion11 Dec 2025 (estimated)
- Study completion11 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Leipzig, Charite University, Berlin, Germany, Technische Universität Dresden, Deutsches Herzzentrum Muenchen, University of Rostock, Ruhr University of Bochum, Universitätsmedizin Mannheim, LMU Klinikum
- Responsible party
- Principal investigator, Oliver Weingärtner, Jena University Hospital
- Investigators
- Oliver Weingaertner, MD, Principal investigator, Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438069
- Sponsor's protocol ID
- 2021-2429
- Acronym
- GIN
- Status last verified
- Jul 2022
- First submitted
- 24 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data that will be shared: Study protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany
- ClinicalTrials.gov ID
- NCT05438069
- Acronym / sponsor ID
- GIN / 2021-2429
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- Universitätsklinikum Leipzig, Charite University, Berlin, Germany, Technische Universität Dresden, Deutsches Herzzentrum Muenchen, University of Rostock, Ruhr University of Bochum, Universitätsmedizin Mannheim, LMU Klinikum
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 11 Dec 2025 (estimated)
- Study completion
- 11 Dec 2025 (estimated)
- First posted
- 29 Jun 2022 (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 German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany
Detailed description
The aim of this retrospective, multi-center analysis is to use individual patient data to determine the extent of the variability in LDL-C reduction in response to inclisiran administration in a real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with elevated LDL-cholesterol (hypercholesterolemia) | – | –Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -patients with elevated LDL-C levels (hypercholesterolemia), who are treated with the siRNA Inclisiran
Key inclusion criteria (2 listed)
- patients with elevated LDL-C levels (hypercholesterolemia) on stable lipid-lowering drugs for at least one month prior to the application of the siRNA Inclisiran
- patients 18 years and older
Key exclusion criteria (1 listed)
- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.
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
LDL-C change
Time frame: 3 months, 6 months, 12 months, 24 months
LDL-C change in mg/dL / mmol/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Individual participant dataSharing planned: Yes. Data that will be shared: Study protocol and individual participant data underlying the results reported in the project report or article, after deidentification. Documents will be available 3 months after publication for 3 years for researchers submitting a structured application, after approval by a committee. Data will be made available for all types of analyses that produce results in the approved application. Requests should be sent informally to oliver.weingaertner@med.uni-jena.de. A data agreement must be signed for access to the data.
Related trials for Hypercholesterolemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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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.
Oliver Weingaertner, MD principal investigator
Jena University Hospital
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 Hypercholesterolemia, run by Jena University Hospital at 1 site in Germany.
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 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2022. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oliver Weingaertner, MD (+4936419324521, oliver.weingaertner@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C change (time frame: 3 months, 6 months, 12 months, 24 months). 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 7 Jul 2022.