QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension
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
1 other identifier
interventional
810
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2024
CompletedFirst Posted
Study publicly available on registry
December 4, 2024
CompletedStudy Start
First participant enrolled
December 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedDecember 6, 2024
November 1, 2024
1.3 years
November 29, 2024
December 3, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
The change in msSBP measured at Week 8 relative to baseline.
Baseline and week 8
Secondary Outcomes (6)
Change From Baseline in Mean Sitting Diastolic BP (msDBP)
Baseline and week 8
Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)
Baseline and week 8
Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP
Baseline and week 8
Percentage of Participants Achieving BP Control
Baseline and week 8
Percentage of Participants Achieving BP Response
Baseline and week 8
- +1 more secondary outcomes
Study Arms (3)
QR12000 75mg
EXPERIMENTALParticipants will be treated with one tablet of QR12000 75mg, one tablet of QR12000 150mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
QR12000 150mg
EXPERIMENTALParticipants will be treated with one tablet of QR12000 150mg, one tablet of QR12000 75mg placebo and one tablet of Sacubitril/valsartan 200 mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Sacubitril/valsartan 200 mg
ACTIVE COMPARATORParticipants will be treated with one tablet of Sacubitril/valsartan 200 mg, one tablet of QR12000 75mg placebo and one tablet of QR12000 150mg placebo once daily for up to 8 weeks. Participants continue with one tablet of QR12000 150mg once daily for 44 weeks during TOP observation period.
Interventions
Matching placebo of QR12000 150mg QD
Matching placebo of Sacubitril/valsartan 200mg QD
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2024
First Posted
December 4, 2024
Study Start
December 30, 2024
Primary Completion
April 30, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
December 6, 2024
Record last verified: 2024-11