A Phase II Clinical Study of QR12000 Compound Tablets in Patients With Moderate to Severe Essential Hypertension

NCT07700875 | Completed Phase 2

• 2 other identifiers: QR12000-GXY-2-01CTR20222568
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the antihypertensive effect of QR12000 Compound Tablets with its single component, QR01019 potassium salt, and with valsartan in patients with moderate to severe essential hypertension.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8

  The change in msSBP measured at Week 8 relative to baseline.

  Baseline and week 8.

Secondary Outcomes (4)

• Percentage of Participants Achieving BP Response

  Baseline, week 2, week 4, week 6 , and week 8.

• Change From Baseline in Mean Sitting Diastolic BP (msDBP)

  Baseline, Week 2, Week 4, Week 6, and Week 8.

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

  Baseline, Week 2, Week 4, Week 6, and Week 8.

• Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) at Week 8

  Baseline and week 8.

Study Arms (5)

QR12000 Compound Tablets 75mg

EXPERIMENTAL

Participants will be treated with one tablet of QR12000 Compound Tablets 75mg

Drug: QR12000 Compound Tablets 75 mg; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg placebo

QR12000 Compound Tablets 150mg

EXPERIMENTAL

Participants will be treated with one tablet of QR12000 Compound Tablets 150mg

Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg placebo

QR01019 potassium salt 50 mg

EXPERIMENTAL

Participants will be treated with one tablet of QR01019 potassium salt 50 mg

Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg placebo

Sacubitril/valsartan 200 mg

ACTIVE COMPARATOR

Participants will be treated with one tablet of Sacubitril/valsartan 200 mg

Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg; Drug: Valsartan 160 mg placebo

Valsartan 160mg

ACTIVE COMPARATOR

Participants will be treated with one tablet of Valsartan160 mg

Drug: QR12000 Compound Tablets 75 mg placebo; Drug: QR12000 Compound Tablets 150 mg placebo; Drug: QR01019 potassium salt 50 mg placebo; Drug: Sacubitril / valsartan 200 mg placebo; Drug: Valsartan 160 mg

Interventions

QR12000 Compound Tablets 75 mg DRUG

QR12000 Compound Tablets 75 mg QD

QR12000 Compound Tablets 75mg

QR12000 Compound Tablets 75 mg placebo DRUG

Matching placebo of QR12000 Compound Tablets 75 mg QD

QR01019 potassium salt 50 mg; QR12000 Compound Tablets 150mg; Sacubitril/valsartan 200 mg; Valsartan 160mg

QR12000 Compound Tablets 150 mg DRUG

QR12000 Compound Tablets 150 mg QD

QR12000 Compound Tablets 150mg

QR12000 Compound Tablets 150 mg placebo DRUG

Matching placebo of QR12000 Compound Tablets 150 mg QD

QR01019 potassium salt 50 mg; QR12000 Compound Tablets 75mg; Sacubitril/valsartan 200 mg; Valsartan 160mg

QR01019 potassium salt 50 mg DRUG

QR01019 potassium salt 50 mg QD

QR01019 potassium salt 50 mg

QR01019 potassium salt 50 mg placebo DRUG

Matching placebo of QR01019 potassium salt 50 mg QD

QR12000 Compound Tablets 150mg; QR12000 Compound Tablets 75mg; Sacubitril/valsartan 200 mg; Valsartan 160mg

Sacubitril / valsartan 200 mg DRUG

Sacubitril / valsartan 200 mg QD

Sacubitril/valsartan 200 mg

Sacubitril / valsartan 200 mg placebo DRUG

Matching placebo of Sacubitril / valsartan 200 mg QD

QR01019 potassium salt 50 mg; QR12000 Compound Tablets 150mg; QR12000 Compound Tablets 75mg; Valsartan 160mg

Valsartan 160 mg DRUG

Valsartan 160 mg QD

Valsartan 160mg

Valsartan 160 mg placebo DRUG

Matching placebo of Valsartan 160mg QD

QR01019 potassium salt 50 mg; QR12000 Compound Tablets 150mg; QR12000 Compound Tablets 75mg; Sacubitril/valsartan 200 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are able to understand and willing to strictly follow the clinical trial protocol to complete the study, and have signed the informed consent form.
• Male or female aged 18 to 75 years (inclusive), with a body mass index (BMI) ≤ 30 kg/m².
• Patients with moderate to severe essential hypertension:
• Newly diagnosed essential hypertension or a history of hypertension but no antihypertensive medication within 4 weeks prior to screening. Qualified subjects will enter the placebo run-in period. The subject's blood pressure at the Screening Visit (V1) and Baseline (V3) must meet the following criteria: at V1, mean sitting systolic blood pressure (msSBP) \> 140 mmHg and/or mean sitting diastolic blood pressure (msDBP) \> 90 mmHg; at V3, 160 mmHg ≤ msSBP \< 190 mmHg and/or 100 mmHg ≤ msDBP \< 120 mmHg.
• Subjects who have been taking antihypertensive medications other than the study drugs as regularly as possible (missed doses ≤ 2 per week) for at least 4 weeks prior to screening, but whose blood pressure remains uncontrolled. After qualifying, subjects will discontinue their previous medications on the day they enter the placebo run-in period. Blood pressure criteria at V1 and V3 must meet: V1 msSBP \> 140 mmHg and/or msDBP \> 90 mmHg; V3 160 mmHg ≤ msSBP \< 190 mmHg and/or 100 mmHg ≤ msDBP \< 120 mmHg. \[Note: "Study drugs" here refer to all investigational treatments in this study (excluding placebo) and other marketed drugs with identical active ingredients, mainly including valsartan 160 mg, sacubitril/valsartan sodium 200 mg, and azilsartan medoxomil potassium 40 mg.\]
• Subjects who are able to communicate and comply with all study requirements, and demonstrate good medication adherence.
• The subject and their sexual partner are willing to have no plans for pregnancy and voluntarily use effective contraception from 2 weeks before screening until 6 months after the last dose of study drug, have no plans for sperm or egg donation, and agree to use one or more non-pharmacological contraceptive measures during sexual intercourse from 2 weeks before screening until 1 month after the last dose of study drug

You may not qualify if:

• Known or suspected secondary hypertension (including but not limited to: primary aldosteronism, pheochromocytoma, Cushing's syndrome, renal hypertension, drug-induced hypertension, etc.).
• Known history of orthostatic hypotension or frequent hypotension after taking antihypertensive medications.
• Planned or concomitant use of other antihypertensive drugs (other than study drugs) during the trial, such as calcium channel blockers (CCB), angiotensin-converting enzyme inhibitors (ACEI), angiotensin II receptor blockers (ARB), diuretics, β-blockers, α-blockers, vasodilators, or traditional Chinese medicines with antihypertensive effects.
• Planned or concomitant use of non-antihypertensive drugs that may affect blood pressure during the trial. Note: Topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticoids (with very low systemic absorption) are allowed. Short-term (≤3 days) systemic glucocorticoid use (intravenous or oral) for prophylaxis (e.g., contrast agent allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity to contact allergens) is permitted; however, systemic glucocorticoids must not be used within 7 days before the primary endpoint.
• Planned or concomitant use of drugs that may affect the metabolism of the investigational drug or comparator, as well as other chemical drugs, biological products, traditional Chinese medicines, or natural medicines deemed unsuitable by the investigator.
• History of severe cerebrovascular disease within 6 months prior to enrollment, such as hypertensive encephalopathy, cerebrovascular injury, cerebral hemorrhage, transient ischemic attack, cerebral infarction, etc.
• History of any of the following severe cardiovascular diseases within 6 months prior to enrollment: chronic heart failure (New York Heart Association \[NYHA\] Class III or IV), acute coronary syndrome, cardiogenic shock, any type of cardiomyopathy, rheumatic heart disease, arrhythmias requiring treatment, and valvular heart disease requiring treatment.
• Severe or malignant retinopathy. Severe retinopathy is defined as retinal hemorrhage, microaneurysms, cotton-wool spots, hard exudates, or a combination thereof; malignant retinopathy is defined as severe retinopathy plus optic disc edema.
• History of angioedema, hereditary or idiopathic angioedema.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin (TBIL) \> 2 × upper limit of normal (ULN) (based on the local laboratory reference ranges); serum creatinine (Cr) \> 1.5 × ULN (based on the local laboratory reference ranges).
• Diabetes mellitus with poor glycemic control (fasting blood glucose \> 11.1 mmol/L).
• Severe depression, anxiety disorder, or severe sleep disorder requiring combined treatment with three or more medications within 12 months before screening.
• Subjects with aortic aneurysm or dissecting aneurysm, history of percutaneous transluminal coronary angioplasty, or cardiac surgery.
• History or current diagnosis of severe bronchial asthma or severe obstructive pulmonary disease.
• Advanced peripheral arterial occlusive disease or Raynaud's syndrome.

Sponsors & Collaborators

• Wuhan Createrna Science and Technology Co., Ltd: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

sacubitril; Valsartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: July 8, 2026
• First Posted: July 14, 2026
• Study Start: December 29, 2022
• Primary Completion: August 20, 2023
• Study Completion: September 11, 2023
• Last Updated: July 14, 2026

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)