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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 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

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

Locations

This trial has no locations.

Sponsors and contacts

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

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: