A Phase II Clinical Study on the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism

Trial statusActive, not recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

This study is a multicenter, randomized, double-blind, placebo-parallel-controlled phase II clinical trial to evaluate the efficacy and safety of HRS-1780 compared with placebo in participants with primary aldosteronism. The study plans to enroll 60 participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, aged ≥ 18 years on the date of signing the informed consent form.

Diagnosed with primary aldosteronism.

Not having taken antihypertensive medication prior to randomization, or having been on a stable antihypertensive regimen .

Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures, and possible adverse reactions, and be capable and willing to comply with the protocol requirements to complete the study.

Disqualifiers

Has known secondary causes of hypertension.

Has previously undergone, or plans to undergo during the study period, adrenal-related surgeries, including adrenalectomy, adrenal ablation, etc.

Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m².

Has had any malignancy of an organ system within 5 years before screening.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-1780 Tablets

    Drug

    HRS-1780 Tablets

  • Placebo

    Drug

    Placebo

Treatment groups

61 Participants
are divided into 2 treatment groups
Group A: HRS-1780 TabletsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in office systolic blood pressure (SBP);

Time frame
up to Week 8

Secondary outcomes

1

Rate of achieving office blood pressure <140/90 mmHg;

Time frame
up to Week 8
2

Rate of achieving office blood pressure <130/80 mmHg;

Time frame
up to Week 8
3

Change from baseline in office diastolic blood pressure (DBP) ;

Time frame
up to Week 8
4

Change from baseline in 24-hour ambulatory blood pressure monitoring (ABPM) mean SBP and DBP ;

Time frame
up to Week 8

Other outcomes

Sponsors and contacts

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