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
Uncontrolled Hypertension
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Phase 2
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 260 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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:
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. 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. NYHA functional heart failure class IV at Screening.
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Quadruple masked
ose 1 of QLS1410
Not reported in this registry record.
Drug: Dose 1 of QLS1410
Dose 2 of QLS1410
Not reported in this registry record.
Drug: Dose 2 of QLS1410
Dose 3 of QLS1410
Not reported in this registry record.
Drug: Dose 3 of QLS1410
placebo
Not reported in this registry record.
Drug: Placebo
Dose 1 of QLS1410 DRUG
Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks
Dose 2 of QLS1410 DRUG
Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks.
Dose 3 of QLS1410 DRUG
Patients will take oral tablets of QLS1410 once daily (QD) for 12 weeks.
Placebo DRUG
Matching placebo tablet administered orally, once daily (QD).
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Primary efficacy endpoint
Time frame: At week 12
Change From Baseline in Mean Seated Systolic BP (SBP)
Secondary measures
Safety endpoint
Time frame: 12 weeks
Number of Participants With Any Adverse Events
Efficacy endpoint
Time frame: At week 4 and 8
Change From Baseline in Mean Seated Systolic BP (SBP)
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (0)
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No locations are listed. Use the official study contact.
Study team and timeline
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 2026-11 Estimated
- Primary completion
- 2027-12 Estimated
- Study completion
- 2028-01 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of QLS1410 Tablets in Patients With Uncontrolled Hypertension (Including Resistant Hypertension) Who Are Being Treated With One or More Antihypertensive Medications.
Ask Wellness Clinical Research
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026