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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
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 uncontrolled hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18-75 years old, male or female.

Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and <180 mmHg.

Meet either item A or B at screening: A. Uncontrolled hypertension (uHTN); B. Resistant hypertension (rHTN).

Mean seated systolic blood pressure (msSBP) prior to randomization was ≥140 mmHg and <180 mmHg.

Disqualifiers

Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.

Compliance with study drug during the run-in period was less than 80% or greater than 120%.

Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke.

Positive results for any of human immunodeficiency virus antibody (HIV), hepatitis C virus antibody (HCV), treponema pallidum antibody (TP); or positive hepatitis B surface antigen (HBsAg) with HBVDNA ≥ 1000 IU/mL.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAL0140

    Drug

    SAL0140 Tablets

  • SAL0140

    Drug

    SAL0140 Tablets

  • SAL0140

    Drug

    SAL0140 Tablets

  • Placebo

    Drug

    Placebo

Treatment groups

252 Participants
are divided into 4 treatment groups
Group A: Low-dose groupExperimental treatment 1 intervention
Group B: Middle-dose groupExperimental treatment 1 intervention
Group C: High-dose groupExperimental treatment 1 intervention
Group D: 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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