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

Participants diagnosed with uncontrolled hypertension were randomly assigned to the low-dose group, middle-dose group, high-dose group or placebo group for a double-blind treatment period. Participants subsequently entered a withdrawal period.

Inclusion criteria

• 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.
• Voluntarily participate in this study and sign the informed consent form.
• Agree to comply with contraception and fertility restrictions of this study.

Exclusion criteria

• 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.
• Patients with active malignant tumors.
• Patients receiving hemodialysis or adhering to strict salt restriction therapy.
• History of adrenal insufficiency.
• History of solid organ or bone marrow transplantation.
• Gastrointestinal diseases or post-gastrointestinal surgery.
• Known or suspected hypersensitivity to aldosterone synthase inhibitors; known or suspected contraindications or hypersensitivity to background medications.
• History of drug abuse or alcohol abuse.
• Blood donation or significant blood loss.