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Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

PHASE3RECRUITING

This is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications.

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Study details:

This study is a Phase 3 trial to evaluate the BP-lowering effect of lorundrostat (an aldosterone synthase inhibitor) in subjects with uncontrolled and resistant hypertension taking between 2 and 5 anti-hypertensive (AHT) medications, one of which must be a thiazide or thiazide-like diuretic. The study consists of a 2-week screening period with a 2-week single-blind run-in period followed by a 12-week randomized, double-blind, placebo-controlled, parallel arm period. Following the randomized period subjects will be offered an opportunity to participate in an open-label extension (OLE) study.

Any subject electing to not participate in the OLE will undergo an end of study (EoS) visit, which will occur after end of treatment (EoT), to complete their participation in the study.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • At least 18 years of age at the time of signing the informed consent form (ICF)
  • At Screening and Randomization: AOBP SBP of ≥135 and ≤180 mmHg plus AOBP DBP of ≥65 and ≤110 mmHg, or AOBP DBP of ≥90 and ≤110 mmHg
  • Taking between 2 and 5 AHT medications
  • History of hypertension lasting at least 6 months prior to Screening
  • Body mass index (BMI) of ≥18 kg/m2 at Screening
  • Exclusion criteria

  • Women who are pregnant, plan to become pregnant, or are breastfeeding
  • Participation in a study involving any investigational device or small-molecule drug within 4 weeks or 6 months for biologic (antibody) drugs prior to the Screening Visit
  • eGFR <45 mL/min/1.73m2 at Screening, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
  • Serum potassium >5.0 mmol/L at Screening or >4.8 mmol/L at Randomization
  • Serum sodium <135 mmol/L (corrected for hyperglycemia) at Screening.
  • History of heart failure, myocardial infarction, stroke, or transient ischemic attack within 6 months prior to the Screening Visit.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-11-22

    Primary completion: 2025-02-01

    Study completion finish: 2025-07-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06153693

    Intervention or treatment

    DRUG: Placebo

    DRUG: lorundrostat Dose 1

    DRUG: lorundrostat Dose 2

    Conditions

    • Hypertension

    Find a site

    Closest Location:

    Royal Hobart Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Hobart Hospital

      Hobart, Tasmania, Australia

    • Castle Hill Medical Centre

      Castle Hill, New South Wales, Australia

    • Renal Research - Gosford

      Gosford, New South Wales, Australia

    • University of Newcastle - John Hunter Hospital (JHH)

      Waratah, New South Wales, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    PLACEBO_COMPARATOR: Placebo
    • Placebo once daily (QD) for 12 weeks
    DRUG: Placebo
    • Placebo once daily (QD) for 12 weeks
    EXPERIMENTAL: Dose 1
    • 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
    DRUG: lorundrostat Dose 1
    • 50 mg lorundrostat Dose 1 once daily (QD) for 12 weeks
    EXPERIMENTAL: Dose 2
    • 50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria
    DRUG: lorundrostat Dose 2
    • 50 mg lorundrostat Dose 1 once daily (QD) for 6 weeks then 100 mg lorundrostat Dose 2 once daily (QD) for 6 weeks for subjects who meet prespecified criteria

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Change from baseline in automated office BP (AOBP) SBP at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placeboNot SpecifiedWeek 6

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Proportion of subjects with AOBP SBP <130 mmHg at Week 6 in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placeboNot SpecifiedWeek 6
    Change from baseline in AOBP SBP at Week 12 in subjects randomized to lorundrostat 50 mg QD with escalation to lorundrostat 100 mg QD compared to subjects randomized to placeboNot SpecifiedWeek 12
    Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medicationsChange from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 2 prescribed AHT medications randomized to placeboWeek 6
    Change from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medicationsChange from baseline in AOBP SBP at Week 6 in subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to lorundrostat 50 mg QD compared to subjects with uncontrolled hypertension on 3 or more prescribed AHT medications (resistant hypertension) randomized to placeboWeek 6
    Change from baseline in AOBP SBP at Week 6 by obesity status in subjects randomized to lorundrostat 50 mg QD compared to subjects randomized to placeboNot SpecifiedWeek 6
    Change from baseline in AOBP SBP at Week 12 in subjects who were escalated to lorundrostat 100 mg QD at week 6 (within-subjects analysis)Not SpecifiedWeek 12

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Efficacy and Safety of Lorundrostat in Subjects with Uncontrolled and Resistant Hypertension

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