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Enrolling by Invitation

NCT Number: NCT07489612

QLS1410 in Participants With Uncontrolled Hypertension

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.

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Key information

Conditions

Hypertension (HTN) Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Qilu Hospital of Shandong University

Jinan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dose 1 of QLS1410

Drug

QLS1410 tablet administered orally, once daily (QD).

Dose 2 of QLS1410

Drug

QLS1410 tablet administered orally, once daily (QD).

Dose 3 of QLS1410

Drug

QLS1410 tablet administered orally, once daily (QD).

Placebo

Drug

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

Primary outcomes

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

    Time frame: At week 12

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

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of QLS1410 in Participants With Uncontrolled Hypertension

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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