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A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

RecruitingPhase 3Ages 18 Years - 130 YearsAllAstraZeneca
NCT07619118 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the effect on low-density lipoprotein-cholesterol (LDL-C) and the safety and tolerability of a fixed dose combination (FDC) of laroprovstat/rosuvastatin versus rosuvastatin alone in patients with hypercholesterolaemia with either a history of a clinical atherosclerotic cardiovascular disease (ASCVD) event or at increased risk for a first clinical ASCVD event.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Participant must be ≥ 18 years of age * Participants must be on a stable dose of all background LLTs * The stable statin dose should be judged as their maximally tolerated dose * Participants should have either history of a clinical ASCVD event or be at increased risk for a first clinical ASCVD event Exclusion Criteria: * Asian origin * Uncontrolled severe hypertension * Uncontrolled T2DM * Inadequately treated hypothyroidism
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What it tests

  • laroprovstat/rosuvastatin 1
  • laroprovstat/rosuvastatin 2
  • laroprovstat/rosuvastatin 3
  • laroprovstat/rosuvastatin 4
  • Placebo to match laroprovstat/rosuvastatin 1,2,3
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Where

45 sites
Research Site
Sun City West, United States
Research Site
Gardena, United States
Research Site
Lomita, United States
Research Site
Pomona, United States
Research Site
Sacramento, United States
Research Site
Jacksonville, United States
Research Site
Miami Lakes, United States
Research Site
Orlando, United States

…and 37 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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