Atherosclerotic cardiovascular disease (ASCVD) MedDRA version: 21.1 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease System Organ Class: 100000004866
Conditions
Interventions
Trade Name: LEQVIO
Product Name: Inclisiran sodium
Product Code: [KJX839]
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Inclisiran
CAS Number: 1639324-58-5
Cur
Sponsors
NOVARTIS PHARMA AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female =40 years of age - Fasting LDL-C =1.8 mmol/L (70 mg/dL) at the Screening Visit - At the Screening Visit, participants must be on a stable (=4 weeks) and well-tolerated lipid-lowering regimen (including e.g. with or without Ezetimibe) that must include a high-intensity statin therapy with either atorvastatin =40 mg QD or rosuvastatin =20 mg QD - Established CV disease, defined as any of the following: - Previous myocardial infarction - Previous ischemic stroke - Symptomatic peripheral arterial disease (PAD), as evidenced by either intermittent claudication with ABI =65 years) yes F.1.3.1 Number of subjects for this age range 6000
Exclusion criteria
Exclusion criteria: - New York Heart Association (NYHA) class III or IV heart failure at the Statin Optimization Screening Visit (if applicable), Screening Visit, or at the Baseline Visit (Day1) - Previous exposure to inclisiran or any other non-mAb PCSK9-targeted therapy, either as an investigational or marketed drug within 2 years prior to the first study visit - Pregnant or nursing (lactating) women - Women of child-bearing potential, unless they are using effective methods of contraception during dosing of study treatment Other exclusion criteria are listed in the clinical study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Inclisiran compared to placebo in reducing the risk of 3P-MACE (composite of CV death, non-fatal MI and non-fatal ischemic stroke) in participants with established ASCVD and a LDL-C =1.8 mmol/L (70 mg/dL);Secondary Objective: Inclisiran compared to placebo in reducing the risk of CV death. Inclisiran compared to placebo in reducing the risk of 4P-MACE (composite of CV death, non-fatal MI, non-fatal ischemic stroke and urgent coronary revascularization). Inclisiran compared to placebo in reducing the risk of all-cause death.;Primary end point(s): Time to the first occurrence of 3P-MACE;Timepoint(s) of evaluation of this end point: From randomization to the first occurrence of 3P-MACE | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to occurrence of CV death. Time to the first occurrence of 4P-MACE. Time to the occurrence of all-cause death.;Timepoint(s) of evaluation of this end point: From randomization to the occurrence of the secondary endpoint(s) | — |
Countries
Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Korea, Republic of, Latvia, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United States
Contacts
Public ContactRegulatory Affairs
Novartis Farma S.p.A.
Outcome results
None listed