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A randomized, double-blind, positive-drug parallel controlled, multicenter phase III trial of the efficacy and safety of S086 tablets in patients with chronic heart failure with reduced ejection fraction (HFrEF)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S086 piece | Experimental | Sacubitril alisartan calcium tablets,60mg,120mg,180mg,240mg |
|
| Sacubitril valsartan sodium tablets | Active Comparator | Sacubitril valsartan sodium tablets,50mg,100mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug | Drug | To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug |
| Measure | Description | Time Frame |
|---|---|---|
| Sacubitril valsartan sodium tablets (trade name: Nohintal) were used as a control to study the efficacy of S086 tablets in the treatment of Chronic heart failure with reduced ejection fraction(HFrEF). | Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%. | the end of 28th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| junbo he | Contact | 13434792084 | 527768709@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People' S Hospital | Recruiting | Shenzhen | Guangdong | 518000 | China |
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Randomized, double-blind, positive drug parallel control, multicenter
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