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NCT05438069 Clinical Trial

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

Hypercholesterolemia Clinical Trial

— GIN  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05438069
Other study ID # 2021-2429
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 11, 2020
Est. completion date December 11, 2025

Study information
Verified date July 2022
Source Jena University Hospital
Contact Oliver Weingaertner, MD
Phone +4936419324521
Email oliver.weingaertner@med.uni-jena.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 11, 2025
Est. primary completion date December 11, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Jena University Hospital Jena

Sponsors (9)
Lead Sponsor Collaborator
Jena University Hospital Charite University, Berlin, Germany, Deutsches Herzzentrum Muenchen, LMU Klinikum, Ruhr University of Bochum, Technische Universität Dresden, Universitätsklinikum Leipzig, Universitätsmedizin Mannheim, University of Rostock

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary LDL-C change LDL-C change in mg/dL / mmol/L 3 months, 6 months, 12 months, 24 months
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