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
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
Treatments tested in this trial
- SAL0140
- SAL0140
- SAL0140
- Placebo