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An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol

NCT03060577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2023-03-24

Study results available
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Summary

This clinical study was designed to assess the efficacy, safety, and tolerability of long-term dosing of inclisiran and evolocumab given as subcutaneous injections in participants with high cardiovascular risk and elevated low-density lipoprotein cholesterol (LDL-C).

Conditions

Interventions

DRUG

Inclisiran

Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.

DRUG

Evolocumab

Evolocumab is a fully human monoclonal antibody that inhibits PCSK9.

Sponsors & Collaborators

Principal Investigators

  • Kausik Ray, MD · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-27
Primary Completion
2021-12-17
Completion
2021-12-17
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

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 NCT03060577 on ClinicalTrials.gov