A Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SAL0140, SAL0140, SAL0140, Placebo.
- Who it may be relevant to
- Registry conditions: Uncontrolled Hypertension. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial of Efficacy and Safety of SAL0140 at Different Doses in Patients With Uncontrolled Hypertension
Overview
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.
Detailed description
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.
Interventions
- Drug SAL0140
SAL0140 Tablets - Drug SAL0140
SAL0140 Tablets - Drug SAL0140
SAL0140 Tablets - Drug Placebo
Placebo
Primary outcome measures
- The baseline change in mean seated systolic blood pressure (msSBP) [Time frame: at week 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Anzhen Hospital Capital Medical University — Beijing
Identifiers
NCT: NCT07654140 · SAL0140A201