Phase 3Recruiting
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia
- Sponsor
- AstraZeneca (Industry)
- Enrollment
- 200 planned
- Conditions
- Hypercholesterolaemia
- Interventions
- laroprovstat/rosuvastatin 1; laroprovstat/rosuvastatin 2; laroprovstat/rosuvastatin 3; laroprovstat/rosuvastatin 4; Placebo to match laroprovstat/rosuvastatin 1,2,3; Placebo to match laroprovstat/rosuvastatin 4; Rosuvastatin 1; Rosuvastatin 2; Rosuvastatin 3; Rosuvastatin 4; Placebo to match Rosuvastatin
- Ages
- adults, older adults
- Registry
- NCT07619118
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Relative change in LDL-C at 8 weeks
History
Primary completion expected
Last registry update
Started
Registered