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200 Participants NeededMy employer runs this trial

Laroprovstat + Rosuvastatin for High Cholesterol

Recruiting at 41 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: AstraZeneca
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults with high cholesterol who are already taking the highest statin dose they can tolerate. Participants must have either had a heart or blood vessel problem in the past, or be at higher risk of having one.

Inclusion Criteria

I am taking the highest dose of statin that I can tolerate.
I am 18 years old or older.
I am taking the same dose of my cholesterol-lowering medications regularly.
See 1 more

Exclusion Criteria

My type 2 diabetes is not well controlled.
Asian origin
I have severe high blood pressure that is not controlled.
See 1 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares a new combination pill (laroprovstat/rosuvastatin) to rosuvastatin alone to see which lowers bad cholesterol (LDL-C) more effectively. People are randomly assigned to different groups and may receive various doses or placebos.

How Is the Trial Designed?

8

Treatment groups

Experimental Treatment

Active Control

Group I: laroprovstat/rosuvastatin dose 4Experimental Treatment2 Interventions
Group II: laroprovstat/rosuvastatin dose 3Experimental Treatment2 Interventions
Group III: laroprovstat/rosuvastatin dose 2Experimental Treatment2 Interventions
Group IV: laroprovstat/rosuvastatin dose 1Experimental Treatment2 Interventions
Group V: rosuvastatin dose 1Active Control2 Interventions
Group VI: rosuvastatin dose 2Active Control2 Interventions
Group VII: rosuvastatin dose 3Active Control2 Interventions
Group VIII: rosuvastatin dose 4Active Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

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