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A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.
A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin and Placebo on LDL-C in LLT-naïve Patients.

NCT07619131

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Hypercholesterolaemia

Interventions: Laroprovstat, Rosuvastatin 1, Rosuvastatin 2, Laroprovstat/Rosuvastatin 1, Placebo to match rosuvastatin

Countries: United States, Bulgaria, Canada, Denmark, Germany, Hungary, Israel, Poland

This is a study to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients. Laroprovstat is a small molecule that reduces the amount of LDL-C in the blood. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Participant must be ≥ 18 years of age
* Participants with no clinical history of atherosclerotic cardiovascular disease (ASCVD) and a 10-year ASCVD risk estimated as low
* Participants who have not received any LLT in the 3 months prior to screening

Exclusion Criteria:

* Asian origin.
* Statin intolerance
* Uncontrolled severe hypertension
* Uncontrolled type 2 diabetes mellitus
* Inadequately treated hypothyroidism
Locations (152)
  • Dothan, Alabama, United States
  • Chandler, Arizona, United States
  • Phoenix, Arizona, United States
  • Huntington Beach, California, United States
  • Loma Linda, California, United States
  • Lomita, California, United States
  • Long Beach, California, United States
  • San Dimas, California, United States
  • Arvada, Colorado, United States
  • Colorado Springs, Colorado, United States
  • Waterbury, Connecticut, United States
  • Clearwater, Florida, United States
  • DeLand, Florida, United States
  • Hollywood, Florida, United States
  • Jacksonville, Florida, United States
  • Lakeland, Florida, United States
  • Miami Lakes, Florida, United States
  • Ocoee, Florida, United States
  • Plantation, Florida, United States
  • Port Orange, Florida, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Conyers, Georgia, United States
  • Decatur, Georgia, United States
  • Hinesville, Georgia, United States
  • Peachtree Corners, Georgia, United States
  • Champaign, Illinois, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Island Lake, Illinois, United States
  • + 122 more on CT.gov