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Not yet recruitingNCT07927556Updated Nov 10, 2026

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of QLS1410 Tablets in Patients With Uncontrolled Hypertension Who Are Receiving One or More Background Drug Treatments

A Phase 2 interventional study of Dose 1 of QLS1410 and Dose 2 of QLS1410 in Uncontrolled Hypertension, sponsored by Qilu Pharmaceutical Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Treatment

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the efficacy and safety of multiple dose strengths of QLS1410 in patients with uncontrolled hypertension.

Read the detailed description

A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of QLS1410 tablets in patients with uncontrolled hypertension. Approximately 260 patients will be randomized in a 1:1:1:1 ratio into 1 of the 4 treatment groups. The study will consist of the following 4 periods: A Screening Period of up to 2 weeks, A Run -in Period of 2 weeks, A Double-Blind Treatment Period of 12 weeks and A Follow-Up Period of 1 weeks.

02

Conditions studied

  • Uncontrolled Hypertension

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's planned enrollment of 260 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 198 studies on the registry; 120 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 the following requirements: have a stable regimen (≥ 4 weeks) of one or more antihypertensive medications at the maximum tolerated dose as determined by the investigator.

Exclusion criteria

Exclusion Criteria:

  1. Mean seated systolic blood pressure (SBP)≥ 180 mmHg.
  2. Mean seated diastolic blood pressure (DBP)≥ 110 mmHg.
  3. Estimated \\< 45 mL/min/1.73m2.
  4. Serum potassium (K+) level \\<3.5 and ≥ 5.0 mmol/L.
  5. Concomitant treatment with both ACEI and ARB.
  6. Has the following known secondary causes of hypertension: renal artery stenosis, uncontrolled hyperthyroidism, uncontrolled hypothyroidism, pheochromocytoma, Cushing's syndrome, aortic coarctation.
  7. functional heart failure class IV at Screening.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    ose 1 of QLS1410

    Drug: Dose 1 of QLS1410

  • Experimental
    Dose 2 of QLS1410

    Drug: Dose 2 of QLS1410

  • Experimental
    Dose 3 of QLS1410

    Drug: Dose 3 of QLS1410

  • Placebo comparator
    placebo

    Drug: Placebo

Interventions

  • DrugDose 1 of QLS1410

    Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks

  • DrugDose 2 of QLS1410

    Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks.

  • DrugDose 3 of QLS1410

    Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks.

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Primary efficacy endpoint

    Change From Baseline in Mean Seated Systolic BP (SBP)

    Time frame: At week 12

Secondary outcomes

  1. Safety endpoint

    Number of Participants With Any Adverse Events

    Time frame: 12 weeks

  2. Efficacy endpoint

    Change From Baseline in Mean Seated Systolic BP (SBP)

    Time frame: At week 4 and 8

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07927556
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Nov 2026 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Nov 10, 2026

Study contacts

Wang Jiguang, M.D
Contact
jiguangw@163.com
13764189476

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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