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

ConditionHypercholesterolaemia
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • laroprovstat/rosuvastatin 1

    Combination product

    daily oral dose of the laroprovstat/rosuvastatin 1

  • laroprovstat/rosuvastatin 2

    Combination product

    daily oral dose of the laroprovstat/rosuvastatin 2

  • laroprovstat/rosuvastatin 3

    Combination product

    daily oral dose of the laroprovstat/rosuvastatin 3

  • laroprovstat/rosuvastatin 4

    Combination product

    daily oral dose of the laroprovstat/rosuvastatin 4

  • Placebo to match laroprovstat/rosuvastatin 1,2,3

    Drug

    Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 1,2,3

  • Placebo to match laroprovstat/rosuvastatin 4

    Drug

    Daily oral dose of placebo to match FDC laroprovstat/rosuvastatin 4

  • Rosuvastatin 1

    Drug

    daily oral dose of rosuvastatin 1

  • Rosuvastatin 2

    Drug

    daily oral dose of rosuvastatin 2

  • Rosuvastatin 3

    Drug

    daily oral dose of rosuvastatin 3

  • Rosuvastatin 4

    Drug

    daily oral dose of rosuvastatin 4

  • Placebo to match Rosuvastatin

    Drug

    daily oral dose of placebo to match rosuvastatin

Treatment groups

200 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: laroprovstat/rosuvastatin dose 1Experimental treatment 2 interventions
Group B: rosuvastatin dose 1Active comparator 2 interventions
Group C: laroprovstat/rosuvastatin dose 2Experimental treatment 2 interventions
Group D: rosuvastatin dose 2Active comparator 2 interventions
Group E: laroprovstat/rosuvastatin dose 3Experimental treatment 2 interventions
Group F: rosuvastatin dose 3Active comparator 2 interventions
Group G: laroprovstat/rosuvastatin dose 4Experimental treatment 2 interventions
Group H: rosuvastatin dose 4Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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