Dose 1 of QLS1410Dose 2 of QLS1410Dose 3 of QLS1410placebo
Dose 1 of QLS1410: QLS1410 tablet administered orally, once daily (QD).
Dose 2 of QLS1410: QLS1410 tablet administered orally, once daily (QD).
Dose 3 of QLS1410: QLS1410 tablet administered orally, once daily (QD).
placebo: Matching placebo tablet administered orally, once daily (QD).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
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
Trial sites (1)
Facility
City
Region
Status
Qilu Hospital of Shandong University
Jinan
China
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.