Hypertension (HTN)Phase 2NCT07489612
QLS1410 in Participants With Uncontrolled Hypertension
A Phase 2 study testing Dose 1 of QLS1410, Dose 2 of QLS1410 and Dose 3 of QLS1410 in people with Hypertension (HTN), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Dose 1 of QLS1410, Dose 2 of QLS1410 and Dose 3 of QLS1410
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 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.
- Conditions
- Hypertension (HTN)
- Being tested
- Dose 1 of QLS1410, Dose 2 of QLS1410, Dose 3 of QLS1410, placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dose 1 of QLS1410Drug
QLS1410 tablet administered orally, once daily (QD).
Dose 2 of QLS1410Drug
QLS1410 tablet administered orally, once daily (QD).
Dose 3 of QLS1410Drug
QLS1410 tablet administered orally, once daily (QD).
placeboDrug
Matching placebo tablet administered orally, once daily (QD).
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 of QLS1410 | Experimental | Not described Receives: Drug: Dose 1 of QLS1410 |
| Dose 2 of QLS1410 | Experimental | Not described Receives: Drug: Dose 2 of QLS1410 |
| Dose 3 of QLS1410 | Experimental | Not described Receives: Drug: Dose 3 of QLS1410 |
| Placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489612
- Sponsor's protocol ID
- QLS1410-201
- Status last verified
- May 2026
- First submitted
- 18 Mar 2026
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of QLS1410 in Participants With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT07489612
- Acronym / sponsor ID
- QLS1410-201
- Conditions
- Hypertension (HTN)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dose 1 of QLS1410QLS1410 tablet administered orally, once daily (QD). | Drug | Dose 1 of QLS1410 |
| Dose 2 of QLS1410QLS1410 tablet administered orally, once daily (QD). | Drug | Dose 2 of QLS1410 |
| Dose 3 of QLS1410QLS1410 tablet administered orally, once daily (QD). | Drug | Dose 3 of QLS1410 |
| placeboMatching placebo tablet administered orally, once daily (QD). | Drug | Placebo |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose 1 of QLS1410, Dose 2 of QLS1410 and Dose 3 of QLS1410 in people with Hypertension (HTN), run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in mean seated systolic blood pressure (SBP) at week 12 (time frame: At week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.