Clinical trial NCT06716970: QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Wuhan Createrna Science and Technology Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 810
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects who can understand and are willing to complying with protocol requirement and sign the informed consent form.
2. Man or woman aged 18 years to 75 years (inclusive), with BMI≤30 kg/m2.
3. 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.
4. Subjects who agree to use adequate contraception from 2 weeks prior to screening to 1 month after last dose.

Exclusion Criteria:

1. History or evidence of a secondary form of hypertension.
2. History of peripheral arterial occlusive disease and Raynaud's syndrome.
3. History of hyperthyroidism.
4. History of hypotension.
5. History of angioedema, drug-related or otherwise.
6. Suffered by severe cerebrovascular disease within 1 year prior to screening.
7. Suffered by severe heart disease within 1 year prior to screening
8. History of severe or malignant retinopathy.
9. History of aortic aneurysm or dissection, cardiac surgery, or percutaneous coronary intervention within 1 year prior to screening.
10. History of malignant tumor within 5 years prior to screening.
11. Poorly controlled diabetes prior to screening
12. History of severe autoimmune diseases.
13. History of severe mental disorder.
14. Clinically significant laboratory abnormalities.
15. History of allergy to the test drug, active control drug, or drugs similar to the test drug and positive control drug or related excipients.
16. 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.
17. Intolerance to the run-in period.
18. Poor medication compliance or other non-compliance during run-in period.
19. 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.
20. History of alcohol abuse within 6 months prior to screening or evidence of drug abuse.
21. Not agree or unable to comply with the restrictions on concomitant treatment during the study.
22. Pregnancy test positive, lactating women, or women planning to become pregnant.
23. High-altitude workers or large motor vehicle drivers and other professionals engaged in hazardous mechanical operations.
24. 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.

Primary outcomes:
measure: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Change From Baseline in Mean Sitting Diastolic BP (msDBP)
timeFrame: Baseline and week 8
measure: Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)
timeFrame: Baseline and week 8
measure: Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP
timeFrame: Baseline and week 8
measure: Percentage of Participants Achieving BP Control
timeFrame: Baseline and week 8
measure: Percentage of Participants Achieving BP Response
timeFrame: Baseline and week 8
measure: Change From Baseline in msSBP/msDBP
timeFrame: Baseline, week 28 and week 52
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References: