Essential HypertensionPhase 3NCT06716970
QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension
A Phase 3 study testing QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg in people with Essential Hypertension, run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 810 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 28 Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Jianping Li, +86 010-83572211, lijianping03455@pkufh.com
About this study
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
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.
- Conditions
- Essential Hypertension
- Being tested
- QR12000 75mg, QR12000 75mg placebo, QR12000 150mg, QR12000 150mg placebo, Sacubitril/valsartan 200mg
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QR12000 75mgDrug
QR12000 75mg QD
QR12000 75mg placeboDrug
Matching placebo of QR12000 75mg QD
QR12000 150mgDrug
QR12000 150mg QD
QR12000 150mg placeboDrug
Matching placebo of QR12000 150mg QD
Sacubitril/valsartan 200mgDrug
Sacubitril/valsartan 200mg QD
Sacubitril/valsartan 200mg placeboDrug
Matching placebo of Sacubitril/valsartan 200mg QD
| Study group | Role | What they receive |
|---|---|---|
| QR12000 75mg | Experimental | Participants 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. Receives: Drug: QR12000 75mg; Drug: QR12000 150mg placebo; Drug: Sacubitril/valsartan 200mg placebo |
| QR12000 150mg | Experimental | Participants 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. Receives: Drug: QR12000 75mg placebo; Drug: QR12000 150mg; Drug: Sacubitril/valsartan 200mg placebo |
| Sacubitril/valsartan 200 mg | Active comparator | Participants 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. Receives: Drug: QR12000 75mg placebo; Drug: QR12000 150mg placebo; Drug: Sacubitril/valsartan 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
The change in msSBP measured at Week 8 relative to baseline.
Measured: Baseline and week 8
Secondary outcomes (6)
Change From Baseline in Mean Sitting Diastolic BP (msDBP)
The change in msDBP measured at Week 8 relative to baseline.
Measured: Baseline and week 8
Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP)
The change in maSBP/maDBP measured at Week 8 relative to baseline.
Measured: Baseline and week 8
Change From Baseline in Daytime ( > 6am and ≤ 10 pm) or Nighttime (> 10 pm and ≤ 6 am) maSBP/maDBP
The change in Daytime or Nighttime maSBP/maDBP measured at Week 8 relative to baseline.
Measured: Baseline and week 8
Percentage of Participants Achieving BP Control
BP control is defined as msSBP <140 mm Hg and msDBP <90 mm Hg.
Measured: Baseline and week 8
Percentage of Participants Achieving BP Response
BP Response is defined as msSBP <140 mm Hg and/or a reduction of ≥20 mm Hg from Baseline and msDBP <90 mm Hg and/or a reduction of ≥10 mm Hg from Baseline.
Measured: Baseline and week 8
Change From Baseline in msSBP/msDBP
The change in msSBP/msDBP measured at Week 28 and Week 52 relative to baseline.
Measured: Baseline, week 28 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Createrna Science and Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716970
- Sponsor's protocol ID
- QR12000-GXY-3-01
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06716970
- Acronym / sponsor ID
- QR12000-GXY-3-01
- Conditions
- Essential Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Wuhan Createrna Science and Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QR12000 75mg | Experimental | Drug: QR12000 75mg, Drug: QR12000 150mg placebo, Drug: Sacubitril/valsartan 200mg placeboParticipants 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 | Experimental | Drug: QR12000 75mg placebo, Drug: QR12000 150mg, Drug: Sacubitril/valsartan 200mg placeboParticipants 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 comparator | Drug: QR12000 75mg placebo, Drug: QR12000 150mg placebo, Drug: Sacubitril/valsartan 200mgParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QR12000 75mgQR12000 75mg QD | Drug | QR12000 75mg |
| QR12000 75mg placeboMatching placebo of QR12000 75mg QD | Drug | QR12000 150mg, Sacubitril/valsartan 200 mg |
| QR12000 150mgQR12000 150mg QD | Drug | QR12000 150mg |
| QR12000 150mg placeboMatching placebo of QR12000 150mg QD | Drug | QR12000 75mg, Sacubitril/valsartan 200 mg |
| Sacubitril/valsartan 200mgSacubitril/valsartan 200mg QD | Drug | Sacubitril/valsartan 200 mg |
| Sacubitril/valsartan 200mg placeboMatching placebo of Sacubitril/valsartan 200mg QD | Drug | QR12000 150mg, QR12000 75mg |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline and week 8
The change in msSBP measured at Week 8 relative to baseline.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing QR12000 75mg, QR12000 150mg and Sacubitril/valsartan 200mg in people with Essential Hypertension, run by Wuhan Createrna Science and Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wuhan Createrna Science and Technology Co.,Ltd (+86 027-68788900, lcyxzx@createrna.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.