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NCT07619118
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
Conditions: Hypercholesterolaemia
Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 200
Sponsor: AstraZeneca
Location: Research Site Sun City West Arizona
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07619118). StuddyBuddy aggregates publicly available trial information.