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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
Sponsor: AstraZeneca
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 130 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-09-10
Completion Date
2027-05-28
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
laroprovstat/rosuvastatin 1
daily oral dose of the laroprovstat/rosuvastatin 1
laroprovstat/rosuvastatin 2
daily oral dose of the laroprovstat/rosuvastatin 2
laroprovstat/rosuvastatin 3
daily oral dose of the laroprovstat/rosuvastatin 3
laroprovstat/rosuvastatin 4
daily oral dose of the laroprovstat/rosuvastatin 4
Placebo to match laroprovstat/rosuvastatin 1,2,3
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3
Placebo to match laroprovstat/rosuvastatin 4
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4
Rosuvastatin 1
daily oral dose of rosuvastatin 1
Rosuvastatin 2
daily oral dose of rosuvastatin 2
Rosuvastatin 3
daily oral dose of rosuvastatin 3
Rosuvastatin 4
daily oral dose of rosuvastatin 4
Placebo to match Rosuvastatin
daily oral dose of placebo to match rosuvastatin
Locations (45)
Research Site
Sun City West, Arizona, United States
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Gardena, California, United States
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Lomita, California, United States
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Pomona, California, United States
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Sacramento, California, United States
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Jacksonville, Florida, United States
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Miami Lakes, Florida, United States
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Orlando, Florida, United States
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Pembroke Pines, Florida, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Peachtree Corners, Georgia, United States
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Evansville, Indiana, United States
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Indianapolis, Indiana, United States
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Zachary, Louisiana, United States
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Beltsville, Maryland, United States
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Rocky Mount, North Carolina, United States
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Statesville, North Carolina, United States
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Wilmington, North Carolina, United States
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Fargo, North Dakota, United States
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Anderson, South Carolina, United States
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Bristol, Tennessee, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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Sugar Land, Texas, United States
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Burwood, Australia
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Hope Island, Australia
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Hoppers Crossing, Australia
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Woolloongabba, Australia
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Cambridge, Ontario, Canada
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Guelph, Ontario, Canada
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Mississauga, Ontario, Canada
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North York, Ontario, Canada
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Stoney Creek, Ontario, Canada
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Toronto, Ontario, Canada
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Berlin, Germany
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Essen, Germany
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Frankfurt, Germany
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Freiburg im Breisgau, Germany
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Hanover, Germany
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Kaiserslautern, Germany
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Leipzig, Germany
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Munich, Germany
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Nuremberg, Germany