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

Phase 3Not Yet RecruitingNCT07619118

AstraZeneca200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Hypercholesterolaemia

Interventions

laroprovstat/rosuvastatin 1COMBINATION_PRODUCT

daily oral dose of the laroprovstat/rosuvastatin 1

laroprovstat/rosuvastatin 2COMBINATION_PRODUCT

daily oral dose of the laroprovstat/rosuvastatin 2

laroprovstat/rosuvastatin 3COMBINATION_PRODUCT

daily oral dose of the laroprovstat/rosuvastatin 3

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Relative change in LDL-C at 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on LDL-C at 8 weeks

Time frame: 8 weeks

Secondary Outcomes

Relative change in Apo B at 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on Apo B at 8 weeks

Time frame: 8 weeks

Relative change in non-HDL-C at 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on non-HDL-C at 8 weeks

Time frame: 8 weeks

Relative change in total cholesterol at 8 weeks

To compare the effect of treatment with laroprovstat/rosuvastatin versus rosuvastatin on total cholesterol at 8 weeks

Time frame: 8 weeks

Central Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

Data from ClinicalTrials.gov

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