QLS1410 in Participants With Uncontrolled Hypertension

Qilu Pharmaceutical

Status and phase: Invitation-only; Phase 2

Conditions: Hypertension (HTN)

Treatments: Drug: Dose 2 of QLS1410; Drug: Dose 1 of QLS1410; Drug: placebo; Drug: Dose 3 of QLS1410

Study type: Interventional

Funder types: Industry

Identifiers

NCT07489612

QLS1410-201

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

260 participants in 4 patient groups, including a placebo group

Dose 1 of QLS1410

Experimental group

Treatment:

Drug: Dose 1 of QLS1410

Dose 2 of QLS1410

Experimental group

Treatment:

Drug: Dose 2 of QLS1410

Dose 3 of QLS1410

Experimental group

Treatment:

Drug: Dose 3 of QLS1410

Placebo

Placebo Comparator group

Treatment:

Drug: placebo