EUCTR2021-003759-40-DE
Active, not recruiting
Phase 1
Efficacy, safety, tolerability and quality of life of ongoing individually optimized lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind multicenter phase IV study in participants with hypercholesterolemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypercholesterolemia
- Sponsor
- ovartis Pharma AG
- Enrollment
- 1760
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •? Male or female participants \=18 years of age.
- •? Participants meeting one of the following CV category:
- •?Very high risk participants with at least one of the following:
- •? Documented Atherosclerotic cardiovascular disease (ASCVD)
- •i Acute coronary syndrome: Unstable angina or myocardial infarction.
- •ii Stable angina.
- •iii Coronary revascularization.
- •iv Unequivocally documented ASCVD upon prior imaging.
- •v Stroke and TIA.
- •vi Peripheral artery disease (PAD).
Exclusion Criteria
- •? Participants on more than one other lipid\-lowering drug on top of
- •statin at screening visit.
- •? Participants with a known intolerance to rosuvastatin at screening or
- •baseline visit.
- •? Previous (within 90 days of screening), current or planned treatment
- •with a monoclonal antibody (mAb) directed towards PCSK9 (e.g.
- •evolocumab, alirocumab) at screening or baseline visit.
- •? Previous exposure to inclisiran or any other non\-mAb PCSK9 targeted
- •therapy, either as an investigational or marketed drug within 2 years
- •prior to screening or baseline visit.
Outcomes
Primary Outcomes
Not specified
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