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Study in Primary Care Evaluating Inclisiran Delivery Implementation + Enhanced Support

NCT04807400 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 892

Last updated 2024-10-09

Study results available
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Summary

The purpose of this study was to evaluate the implementation of inclisiran in a regional primary care setting in the UK

Inclisiran, also known as KJX839, is a medication made to reduce the level of "bad" cholesterol (LDL-cholesterol) in the blood. Inclisiran works in a way that makes the liver produce less of a substance called 'PCSK9'. PCSK9 reduces the ability of the liver to remove LDL-cholesterol from the blood. By lowering the production of PCSK9, Inclisiran leads to more LDL-cholesterol being removed by the liver from the blood, thereby reducing LDL-cholesterol overall.

Conditions

Interventions

DRUG

Inclisiran

Inclisiran Sodium 300mg on Day 1 and Day 90 by subcutaneous injection

BEHAVIORAL

Behavioural Support

Regular telephone based behavioural support programme delivered throughout the study period, as measured by point of care testing device.

DRUG

Background lipid lowering therapy

lipid-lowering therapy (such as a statin and/or ezetimibe) as background therapy

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2023-01-13
Completion
2023-01-13
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04807400 on ClinicalTrials.gov