Hypertension (HTN)
Conditions
Brief summary
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
DRUGDose 1 of QLS1410
QLS1410 tablet administered orally, once daily (QD).
DRUGDose 2 of QLS1410
QLS1410 tablet administered orally, once daily (QD).
DRUGDose 3 of QLS1410
QLS1410 tablet administered orally, once daily (QD).
DRUGplacebo
Matching placebo tablet administered orally, once daily (QD).
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female participants must be ≥ 18 years old. 2. Mean seated SBP ≥ 140 mmHg at Screening and at Baseline.. 3. 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
1. Mean seated systolic blood pressure (SBP)≥ 180 mmHg. 2. Mean seated diastolic blood pressure (DBP)≥ 110 mmHg. 3. Estimated glomerular filtration rate \< 45 mL/min/1.73m2. 4. Serum potassium (K+) level \<3.5 and ≥ 5.0 mmol/L. 5. 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. 6. NYHA functional heart failure class IV at Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean seated systolic blood pressure (SBP) at week 12 | At week 12 | To assess the effect of QLS1410 versus placebo on the mean seated systolic blood pressure (SBP) at week 12 |
Countries
China
Outcome results
None listed