信立泰SAL0140片启动Ⅱ期临床 适应症为未控制高血压

Core Viewpoint - Shenzhen Sinopharm's SAL0140 tablet is undergoing a Phase II clinical trial to evaluate its efficacy and safety in treating uncontrolled hypertension patients [1][2]. Group 1: Clinical Trial Details - The clinical trial is a randomized, double-blind, placebo-controlled, multi-center study [1]. - The trial has been registered under the number CTR20254681, with the first public information date set for November 25, 2025 [1]. - The primary objective is to assess the efficacy of different doses of SAL0140 in patients with uncontrolled hypertension [1]. - Secondary objectives include evaluating the safety of SAL0140 and its pharmacokinetic characteristics in the same patient group [1]. Group 2: Patient and Drug Information - SAL0140 is a chemical drug indicated for uncontrolled hypertension, defined as blood pressure not reaching treatment goals (systolic ≥140 mmHg or diastolic ≥90 mmHg) [1]. - The trial aims to enroll 252 participants, and the current status is ongoing (not yet recruiting) [2]. Group 3: Endpoints and Measurements - Primary endpoint includes the change in mean sitting systolic blood pressure (msSBP) from baseline at the end of the double-blind treatment period [1]. - Secondary endpoints consist of changes in msSBP, mean sitting diastolic blood pressure (msDBP), mean arterial pressure (MAP), adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and electrocardiograms [1].