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

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

Treatment groups

252 Participants
are divided into 4 treatment groups