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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
SAL0140
DrugSAL0140 Tablets
SAL0140
DrugSAL0140 Tablets
SAL0140
DrugSAL0140 Tablets
Placebo
DrugPlacebo
Treatment groups
Trial outcomes
Primary outcomes
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
Sponsors and contacts
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