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Clinical Trials/EUCTR2021-003759-40-BG
EUCTR2021-003759-40-BG
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

ovartis Pharma AG0 sites1,760 target enrollmentMarch 28, 2022
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ConditionsHypercholesterolemiaMedDRA version: 21.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
DrugsLeqvio 284 mg solution for injection in pre-filled syringe

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Hypercholesterolemia
Sponsor
ovartis Pharma AG
Enrollment
1760
Status
Active, not recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 28, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

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.
  • •? Previous, current or planned treatment with LDL\-apheresis at screening or baseline visit.
  • •? Liver and CK: (a) Active liver disease defined as any current infectious, neoplastic, or metabolic pathology of the liver or (b) unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation \>3x ULN, or total bilirubin elevation \> 2x ULN (except for participants with Gilbert's syndrome), or (c) creatine kinase (CK) \>5x ULN at screening or baseline visit.
  • •? Participant with severe renal impairment defined by eGFR \<30 mL/min/1\.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at screening or baseline visit.
  • •? Acute coronary syndrome, ischemic stroke or TIA, coronary revascularization or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease \< 3 months prior to the screening or baseline visit.
  • •? Heart failure New York Heart Association (NYHA) class IV at screening or baseline visit
  • •? Pregnant or nursing (lactating) women at screening or baseline visit.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
Study to understand if inclisiran is better than a placebo at lowering LDL-cholesterol, is safe and can have an impact on patient quality of life, when given along with other lipid lowering medications.HypercholesterolemiaMedDRA version: 21.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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