Not yet recruiting NCT06716970
QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QR12000 75mg, QR12000 75mg placebo, QR12000 150mg, QR12000 150mg placebo.
- Who it may be relevant to
- Registry conditions: Essential Hypertension. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Randomized, Double-blind, and Active-controlled Parallel Study to Evaluate the Efficacy and Safety of QR12000 Compound Tablets and Sacubitril/valsartan Tablets in Patients with Moderate to Severe Essential Hypertension
Overview
The purpose of the study is to evaluate the efficacy and safety of QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg in patients with moderate to severe essential hypertension.
Interventions
- Drug QR12000 75mg
QR12000 75mg QD - Drug QR12000 75mg placebo
Matching placebo of QR12000 75mg QD - Drug QR12000 150mg
QR12000 150mg QD - Drug QR12000 150mg placebo
Matching placebo of QR12000 150mg QD - Drug Sacubitril/valsartan 200mg
Sacubitril/valsartan 200mg QD - Drug Sacubitril/valsartan 200mg placebo
Matching placebo of Sacubitril/valsartan 200mg QD
Primary outcome measures
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [Time frame: Baseline and week 8]
Secondary outcome measures (6)
- Change From Baseline in Mean Sitting Diastolic BP (msDBP) [Time frame: Baseline and week 8]
- Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) [Time frame: Baseline and week 8]
- Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP [Time frame: Baseline and week 8]
- Percentage of Participants Achieving BP Control [Time frame: Baseline and week 8]
- Percentage of Participants Achieving BP Response [Time frame: Baseline and week 8]
- Change From Baseline in msSBP/msDBP [Time frame: Baseline, week 28 and week 52]
Eligibility criteria
Inclusion criteria
- Subjects who can understand and are willing to complying with protocol requirement and sign the informed consent form.
- Man or woman aged 18 years to 75 years (inclusive), with BMI≤30 kg/m2.
- Patients with moderate to severe hypertension. Untreated patients must have an msSBP ≥ 160 mmHg and < 190 mmHg at the screening and randomization visit; Treated patients must have an msSBP≥150 mmHg and <180 mmHg or msSBP≥140 mmHg and <170 mmHg at the screening visit based on numbers of antihypertensive and msSBP≥160 mmHg <190 mmHg at the randomization visit; Patients must have an absolute difference of ≤20 mmHg in msSBP between randomization visit and the immediately preceding visit.
- Subjects who agree to use adequate contraception from 2 weeks prior to screening to 1 month after last dose.
Exclusion criteria
- History or evidence of a secondary form of hypertension.
- History of peripheral arterial occlusive disease and Raynaud's syndrome.
- History of hyperthyroidism.
- History of hypotension.
- History of angioedema, drug-related or otherwise.
- Suffered by severe cerebrovascular disease within 1 year prior to screening.
- Suffered by severe heart disease within 1 year prior to screening
- History of severe or malignant retinopathy.
- History of aortic aneurysm or dissection, cardiac surgery, or percutaneous coronary intervention within 1 year prior to screening.
- History of malignant tumor within 5 years prior to screening.
- Poorly controlled diabetes prior to screening
- History of severe autoimmune diseases.
- History of severe mental disorder.
- Clinically significant laboratory abnormalities.
- History of allergy to the test drug, active control drug, or drugs similar to the test drug and positive control drug or related excipients.
- Undergone gastrointestinal surgery that could significantly alter drug absorption, distribution, metabolism, and excretion, or with severe gastrointestinal diseases, dysphagia, or recurrent vomiting that causes difficulty in eating or taking medication.
- Intolerance to the run-in period.
- Poor medication compliance or other non-compliance during run-in period.
- Participated in any interventional clinical trial within 3 months prior to screening, plan to participate in another clinical trial during the period of this trial, or plan to participate in another clinical trial within 1 month after the end of this trial.
- History of alcohol abuse within 6 months prior to screening or evidence of drug abuse.
- Not agree or unable to comply with the restrictions on concomitant treatment during the study.
- Pregnancy test positive, lactating women, or women planning to become pregnant.
- High-altitude workers or large motor vehicle drivers and other professionals engaged in hazardous mechanical operations.
- Other conditions that by the investigator's discretion may interfere with efficacy or safety assessment of the study, or pose a great risk to the subject.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT06716970 · QR12000-GXY-3-01