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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QR12000 75mg | Drug | QR12000 75mg QD |
| |
| QR12000 75mg placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Sitting Diastolic BP (msDBP) | The change in msDBP measured at Week 8 relative to baseline. | Baseline and week 8 |
| Change From Baseline in Mean Ambulatory Systolic/Diastolic BP (maSBP/maDBP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wuhan Createrna Science and Technology Co.,Ltd | Contact | +86 027-68788900 | lcyxzx@createrna.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China |
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| Drug |
Matching placebo of QR12000 75mg QD |
|
| QR12000 150mg | Drug | QR12000 150mg QD |
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| QR12000 150mg placebo | Drug | Matching placebo of QR12000 150mg QD |
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| Sacubitril/valsartan 200mg | Drug | Sacubitril/valsartan 200mg QD |
|
| Sacubitril/valsartan 200mg placebo | Drug | Matching placebo of Sacubitril/valsartan 200mg QD |
|
The change in maSBP/maDBP measured at Week 8 relative to baseline.
| 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. | Baseline and week 8 |
| Percentage of Participants Achieving BP Control | BP control is defined as msSBP <140 mm Hg and msDBP <90 mm Hg. | 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. | 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. | Baseline, week 28 and week 52 |
| 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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