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Clinical Trials in the UK / NCT05399992
Active, not recruiting Observational

Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD

NCT05399992 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Observational
Started
2022-09-12
Last updated
2026-02-03

Condition(s) studied

Primary HypercholesterolemiaMixed Dyslipidemia

Investigational drug(s) / intervention(s)

Inclisiran

Inclisiran: Prospective observational study. There is no treatment allocation. Patients who are eligible to receive inclisiran will be enrolled into this study.

Study summary

This observational prospective study aims to evaluate the LDL-C change and adherence to inclisiran in combination with other lipid lowering therapies or lipid lowering treatments (LLTs) under conditions of routine clinical practice.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants who are 18 years or older 2. Participants with hypercholesterolemia having a diagnosis of ASCVD, ASCVD RE or HeFH 3. Participants who are not at LDL-C goal as per their CV risk according to respective clinical guidelines 4. Participants who per physician's criteria need to optimize their LLT 5. Participants who provide written informed consent to participate in the study 6. Participants who initiate inclisiran under conditions per local label and have LDL-C values available at baseline or within 3 months before treatment initiation. Exclusion Criteria: 1. Participants that have received inclisiran previously 2. Participants participating in a clinical trial with investigational product 3 Participants switching from previous PCSK9 mab treatment (within 90 days prior to Index date)

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Novartis Investigative Site Feldkirch Austria
Novartis Investigative Site Graz Austria
Novartis Investigative Site Linz Austria
Novartis Investigative Site Sankt Veit im Pongau Austria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Vienna Austria
Novartis Investigative Site Shenzhen Guangdong
Novartis Investigative Site Holon Gush Dan
Novartis Investigative Site Petah Tikva Israel
Novartis Investigative Site Tel Aviv Israel
Novartis Investigative Site Kuala Lumpur Kuala Lumpur
Novartis Investigative Site Kuala Lumpur Malaysia
Novartis Investigative Site Riyadh Saudi
Novartis Investigative Site Jeddah Saudi Arabia
Novartis Investigative Site Tabuk Saudi Arabia
Novartis Investigative Site Fribourg CH
Novartis Investigative Site Basel Switzerland
Novartis Investigative Site Geneva Switzerland
Novartis Investigative Site Lausanne Switzerland
Novartis Investigative Site Olten Switzerland
Novartis Investigative Site Sankt Gallen Switzerland
Novartis Investigative Site Zurich Switzerland
Novartis Investigative Site Zurich Switzerland
Novartis Investigative Site Abu Dhabi Abu Dhabi Emirate
Novartis Investigative Site Dubai United Arab Emirates
Novartis Investigative Site Abu Dhabi United Arab Emirates
Novartis Investigative Site Al Ain City United Arab Emirates
Novartis Investigative Site Dubai United Arab Emirates
Novartis Investigative Site High Wycombe Buckinghamshire
Novartis Investigative Site Louth Lincolnshire
Novartis Investigative Site Sunderland Tyne and Wear
Novartis Investigative Site Belfast United Kingdom
Novartis Investigative Site Bromwich United Kingdom
Novartis Investigative Site Burton-on-Trent United Kingdom
Novartis Investigative Site Cardiff United Kingdom
Novartis Investigative Site Hull United Kingdom
Novartis Investigative Site Lancaster United Kingdom
Novartis Investigative Site Liverpool United Kingdom
Novartis Investigative Site London United Kingdom
Novartis Investigative Site Middlesex United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05399992 on ClinicalTrials.gov ↗ ← All trials in the UK