QLS1410 in Participants With Uncontrolled Hypertension

NCT07489612 | Enrolling By Invitation Phase 2

• 1 other identifier: QLS1410-201
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension (HTN)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean seated systolic blood pressure (SBP) at week 12

  To assess the effect of QLS1410 versus placebo on the mean seated systolic blood pressure (SBP) at week 12

  At week 12

Study Arms (4)

Dose 1 of QLS1410

EXPERIMENTAL

Drug: Dose 1 of QLS1410

Dose 2 of QLS1410

EXPERIMENTAL

Drug: Dose 2 of QLS1410

Dose 3 of QLS1410

EXPERIMENTAL

Drug: Dose 3 of QLS1410

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

Dose 1 of QLS1410 DRUG

QLS1410 tablet administered orally, once daily (QD).

Dose 1 of QLS1410

Dose 2 of QLS1410 DRUG

QLS1410 tablet administered orally, once daily (QD).

Dose 2 of QLS1410

Dose 3 of QLS1410 DRUG

QLS1410 tablet administered orally, once daily (QD).

Dose 3 of QLS1410

placebo DRUG

Matching placebo tablet administered orally, once daily (QD).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

CN (1)