SAL0140 at different doses for uncontrolled hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled Phase II study to assess the efficacy and safety of low, middle, and high doses of SAL0140 in adults with uncontrolled hypertension. Participants are randomly assigned to one of three SAL0140 dose groups or placebo during a double-blind treatment period, followed by a withdrawal phase. The study monitors changes in blood pressure and safety outcomes, with adults 18 to 75 who meet criteria for uncontrolled or resistant hypertension. The trial is conducted at a single site in Beijing, sponsored by Shenzhen Salubris Pharmaceuticals with local collaboration as applicable.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients 18-75 years old, male or female.
2. Mean seated systolic blood pressure (msSBP) at screening was ≥140 mmHg and \<180 mmHg.
3. Meet either item A or B at screening: A. Uncontrolled hypertension (uHTN); B. Resistant hypertension (rHTN).
4. Mean seated systolic blood pressure (msSBP) prior to randomization was ≥140 mmHg and \<180 mmHg.
5. Voluntarily participate in this study and sign the informed consent form.
6. Agree to comply with contraception and fertility restrictions of this study.

Exclusion Criteria:

1. Severe hypertension (msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg); malignant hypertension, hypertensive emergency, hypertensive crisis, hypertensive encephalopathy, etc.
2. Compliance with study drug during the run-in period was less than 80% or greater than 120%.
3. Hypertension complicated with the following conditions: acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, stroke.
4. 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.
5. Patients with active malignant tumors.
6. Patients receiving hemodialysis or adhering to strict salt restriction therapy.
7. History of adrenal insufficiency.
8. History of solid organ or bone marrow transplantation.
9. Gastrointestinal diseases or post-gastrointestinal surgery.
10. Known or suspected hypersensitivity to aldosterone synthase inhibitors; known or suspected contraindications or hypersensitivity to background medications.
11. History of drug abuse or alcohol abuse.
12. Blood donation or significant blood loss.

Where it's running

• Beijing Anzhen Hospital Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jun Cai, professor
• Email: caijun7879@126.com
• Phone: 13810615602

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting at 18 sites Phase 2 Vanda Pharmaceuticals · Phoenix, Arizona and 27 other locations · NCT07090161

• SAL0140 safety and dosing in healthy Chinese adults

  This project will test whether SAL0140 is safe, well tolerated, and how it is processed by the body in healthy Chinese adults to guide dosing for uncontrolled hypertension.

  Recruiting Phase 1 Shenzhen Salubris Pharmaceuticals Co., Ltd. · Guangzhou, Guangdong · NCT07051603

• Adaptive program to reduce food insecurity for people with uncontrolled high blood pressure

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• Renal pelvic denervation for adults with uncontrolled high blood pressure

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.