QLS1410 in Participants 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: Dose 1 of QLS1410, Dose 2 of QLS1410, Dose 3 of QLS1410, placebo.
- Who it may be relevant to
- Registry conditions: Hypertension (HTN). Basic parameters: from 18 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 →
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Official title
A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of QLS1410 in Participants With Uncontrolled Hypertension
Overview
The goal of this clinical trial is to measure the efficacy and safety of QLS1410 in participants with uncontrolled hypertension (uHTN) or treatment-resistant hypertension (rHTN). The main objective is to compare the difference in systolic blood pressure（SBP) change from baseline at Week 12 of treatment between participants receiving QLS1410 tablets and participants receiving placebo tablets.
Interventions
- Drug Dose 1 of QLS1410
QLS1410 tablet administered orally, once daily (QD). - Drug Dose 2 of QLS1410
QLS1410 tablet administered orally, once daily (QD). - Drug Dose 3 of QLS1410
QLS1410 tablet administered orally, once daily (QD). - Drug placebo
Matching placebo tablet administered orally, once daily (QD).
Primary outcome measures
- Change from baseline in mean seated systolic blood pressure (SBP) at week 12 [Time frame: At week 12]
Eligibility criteria
Inclusion criteria
- Male or female participants must be ≥ 18 years old.
- Mean seated SBP ≥ 140 mmHg at Screening and at Baseline..
- Fulfil at least 1 of the following 2 criteria:
- Uncontrolled Hypertension (uHTN) subpopulation: have a stable regimen (≥ 4 weeks) of 2 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
- Resistant Hypertension (rHTN) subpopulation: have a stable regimen (≥ 4 weeks) of ≥ 3 antihypertensive medications, from different therapeutic classes (at least one must be a diuretic), at maximum tolerated dose in the judgement of the Investigator.
Exclusion criteria
- Mean seated systolic blood pressure (SBP)≥ 180 mmHg.
- Mean seated diastolic blood pressure (DBP)≥ 110 mmHg.
- Estimated glomerular filtration rate < 45 mL/min/1.73m2.
- Serum potassium (K+) level <3.5 and ≥ 5.0 mmol/L.
- Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled or untreated hyperthyroidism, uncontrolled or untreated hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
- NYHA functional heart failure class IV at Screening.
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
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT07489612 · QLS1410-201