A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Rosuvastatin on LDL-C in Patients With Hypercholesterolaemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: laroprovstat/rosuvastatin 1, laroprovstat/rosuvastatin 2, laroprovstat/rosuvastatin 3, laroprovstat/rosuvastatin 4.
- Who it may be relevant to
- Registry conditions: Hypercholesterolaemia. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase III Randomised, Double-Blind, Parallel-Group Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Rosuvastatin on Low-Density Lipoprotein Cholesterol in Patients With Hypercholesterolaemia
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.
Interventions
- Combination product laroprovstat/rosuvastatin 1
daily oral dose of the laroprovstat/rosuvastatin 1 - Combination product laroprovstat/rosuvastatin 2
daily oral dose of the laroprovstat/rosuvastatin 2 - Combination product laroprovstat/rosuvastatin 3
daily oral dose of the laroprovstat/rosuvastatin 3 - Combination product laroprovstat/rosuvastatin 4
daily oral dose of the laroprovstat/rosuvastatin 4 - Drug Placebo to match laroprovstat/rosuvastatin 1,2,3
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3 - Drug Placebo to match laroprovstat/rosuvastatin 4
Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4 - Drug Rosuvastatin 1
daily oral dose of rosuvastatin 1 - Drug Rosuvastatin 2
daily oral dose of rosuvastatin 2 - Drug Rosuvastatin 3
daily oral dose of rosuvastatin 3 - Drug Rosuvastatin 4
daily oral dose of rosuvastatin 4
Primary outcome measures
- Relative change in LDL-C at 8 weeks [Time frame: 8 weeks]
Secondary outcome measures (3)
- Relative change in Apo B at 8 weeks [Time frame: 8 weeks]
- Relative change in non-HDL-C at 8 weeks [Time frame: 8 weeks]
- Relative change in total cholesterol at 8 weeks [Time frame: 8 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07619118 · D7961C00001 · 2026-526258-15-00