NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07619118

Not Yet RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Hypercholesterolaemia

Interventions: laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2, laroprovstat/rosuvastatin 3, laroprovstat/rosuvastatin 4, Placebo to match laroprovstat/rosuvastatin 1,2,3

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 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 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

Exclusion Criteria:

* Asian origin
* Uncontrolled severe hypertension
* Uncontrolled T2DM
* Inadequately treated hypothyroidism