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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20222568 | Registry Identifier | www.chinadrugtrials.org.cn |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QR12000 Compound Tablets 75mg | Experimental | Participants will be treated with one tablet of QR12000 Compound Tablets 75mg |
|
| QR12000 Compound Tablets 150mg | Experimental | Participants will be treated with one tablet of QR12000 Compound Tablets 150mg |
|
| QR01019 potassium salt 50 mg | Experimental | Participants will be treated with one tablet of QR01019 potassium salt 50 mg |
|
| Sacubitril/valsartan 200 mg | Active Comparator | Participants will be treated with one tablet of Sacubitril/valsartan 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QR12000 Compound Tablets 75 mg | Drug | QR12000 Compound Tablets 75 mg QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 at week 2, week 4, week 6 , and week 8. | Baseline, week 2, week 4, week 6 , and week 8. |
| Change From Baseline in Mean Sitting Diastolic BP (msDBP) |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shangdong | China |
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| Valsartan 160mg | Active Comparator | Participants will be treated with one tablet of Valsartan160 mg |
|
| QR12000 Compound Tablets 75 mg placebo |
| Drug |
Matching placebo of QR12000 Compound Tablets 75 mg QD |
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| QR12000 Compound Tablets 150 mg | Drug | QR12000 Compound Tablets 150 mg QD |
|
| QR12000 Compound Tablets 150 mg placebo | Drug | Matching placebo of QR12000 Compound Tablets 150 mg QD |
|
| QR01019 potassium salt 50 mg | Drug | QR01019 potassium salt 50 mg QD |
|
| QR01019 potassium salt 50 mg placebo | Drug | Matching placebo of QR01019 potassium salt 50 mg QD |
|
| Sacubitril / valsartan 200 mg | Drug | Sacubitril / valsartan 200 mg QD |
|
| Sacubitril / valsartan 200 mg placebo | Drug | Matching placebo of Sacubitril / valsartan 200 mg QD |
|
| Valsartan 160 mg | Drug | Valsartan 160 mg QD |
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| Valsartan 160 mg placebo | Drug | Matching placebo of Valsartan 160mg QD |
|
The change in msDBP measured at Week 2, Week 4, Week 6, and Week 8 relative to baseline. |
| Baseline, Week 2, Week 4, Week 6, and Week 8. |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | The change in msSBP measured at Week 2, Week 4, Week 6, and Week 8 relative to baseline. | Baseline, Week 2, Week 4, Week 6, and Week 8. |
| Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) at Week 8 | The change in maSBP/maDBP measured at Week 8 relative to baseline. | Baseline and week 8. |
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000717211 | sacubitril |
| D000068756 | Valsartan |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
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