A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Primary Aldosteronism

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

About this trial

This is a multicenter, randomized, double-blind, placebo-controlled phase II study designed to explore the efficacy and safety of different doses of SAL0140 in primary aldosteronism.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 years , regardless of gender.

Diagnosed with primary aldosteronism (PA).

Mean seated office systolic blood pressure (msSBP) ≥145 mmHg.

Receiving stable background antihypertensive therapy.

Disqualifiers

Mean seated office systolic blood pressure (msSBP) ≥180 mmHg and/or mean seated office diastolic blood pressure (msDBP) ≥110 mmHg.

History or diagnosis of malignant hypertension, hypertensive emergency, hypertensive crisis or hypertensive encephalopathy.

History or diagnostic evidence of other secondary hypertension.

Prior surgical resection for adrenal adenoma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAL0140 Tablets

    Drug

    Drug: SAL0140 Tablets

  • SAL0140 Tablets

    Drug

    SAL0140 Tablets

  • SAL0140 placebo

    Drug

    Placebo

Treatment groups

50 Participants
are divided into 3 treatment groups
Group A: Low-dose groupExperimental treatment 1 intervention
Group B: High-dose groupExperimental treatment 1 intervention
Group C: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The baseline change in mean seated systolic blood pressure (msSBP)

Change from baseline in mean seated systolic blood pressure (msSBP) after 12 weeks of randomized, double-blind treatment

Time frame
at week 12

Secondary outcomes

Other outcomes

Sponsors and contacts

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