QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension

Launched by WUHAN CREATERNA SCIENCE AND TECHNOLOGY CO., LTD · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a new medication called QR12000 in patients who have moderate to severe essential hypertension, which is a condition where the blood pressure is consistently high and can lead to serious health problems. The study will compare different doses of QR12000 with an existing medication, Sacubitril/valsartan, to see how well they work in controlling blood pressure.

To be eligible for this trial, participants should be between 18 and 75 years old, have a body mass index (BMI) of 30 or less, and have moderate to severe hypertension. This means they should have specific blood pressure measurements that indicate their condition. Participants will need to agree to follow the study guidelines and sign consent forms. The trial is not yet recruiting, so it’s not open for enrollment at this time. Those who join can expect regular check-ups to monitor their health and blood pressure during the study, and they will need to follow certain rules, like using contraception if they are of childbearing age.

Gender

ALL

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.