A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAstraZeneca

About 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Asian origin

Uncontrolled severe hypertension

Uncontrolled T2DM

Inadequately treated hypothyroidism

Trial design

Treatments tested in this trial

  • 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

Treatment groups

200 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators