Trial to Evaluate the Effect of Inclisiran Treatment on Low Density Lipoprotein Cholesterol (LDL-C) in Subjects With Heterozygous Familial Hypercholesterolemia (HeFH)
Completed
The Medicines Company
Phase 3
2017-11-28
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with
HeFH and elevated LDL-C to evaluate the efficacy, safety, and tolerability of subcutaneous
(SC) injection(s) of inclisiran. The study will be multicenter and international.
Inclisiran for Participants With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol
Completed
The Medicines Company
Phase 3
2017-12-21
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with
ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to
evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s).
The study will be a multicenter study in the United States.
Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol
Completed
The Medicines Company
Phase 3
2017-11-01
This is a Phase III, placebo-controlled, double-blind, randomized study in participants with
ASCVD or ASCVD-Risk equivalents and elevated LDL-C despite maximum tolerated dose of LDL-C
lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC)
inclisiran injection(s). The study will be an international multicenter study (non-United
States).
A Randomized Trial Assessing the Effects of Inclisiran on Clinical Outcomes Among People With Cardiovascular Disease
Recruiting
Novartis Pharmaceuticals
Phase 3
2018-10-30
ORION-4 is a research study coordinated by the University of Oxford and co-sponsored by The
University of Oxford and Novartis (Protocol: CTSU_MDCO-PCS-17-01 (CKJX839B12301)). The study
aims to find out if a new cholesterol-lowering injection (inclisiran) safely lowers the risk
of heart attacks and strokes in people who have already had one of these conditions, or who
have had an operation or procedure to treat blocked arteries.
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