German Inclisiran Network: Retrospective Registry of Patients Being Treated With the siRNA Inclisiran in Germany

NCT ID: NCT05438069

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-11

Study Completion Date

2025-12-11

Brief Summary

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The German Inclisiran Network is a registry of patients with hypercholesterinemia on treatment with the siRNA inclisiran in Germany

Detailed Description

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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

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Hypercholesterolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with elevated LDL-cholesterol (hypercholesterolemia)

Application of si RNA Inclisiran to reduce serum LDL-cholesterol levels.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- patients who do not qualify for treatment with the siRNA inclisiran according to the G-BA (Gemeinsamer Bundesausschuß) in Germany.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Leipzig

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role collaborator

University of Rostock

OTHER

Sponsor Role collaborator

Ruhr University of Bochum

OTHER

Sponsor Role collaborator

Universitätsmedizin Mannheim

OTHER

Sponsor Role collaborator

LMU Klinikum

OTHER

Sponsor Role collaborator

Jena University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Oliver Weingärtner

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Weingaertner, MD

Role: PRINCIPAL_INVESTIGATOR

Jena University Hospital

Locations

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Jena University Hospital

Jena, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Oliver Weingaertner, MD

Role: CONTACT

+4936419324521

Martin Foerster, PhD

Role: CONTACT

+4936419325818

Facility Contacts

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Oliver Weingärtner, MD

Role: primary

+4936419324521

Martin Foerster, PhD

Role: backup

+4936419325818

Other Identifiers

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2021-2429

Identifier Type: -

Identifier Source: org_study_id

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