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To Evaluate the Safety, Efficacy, and Pharmacokinetic/Pharmacodynamics Characteristics of JMKX003142 injection Administered Randomly,Double-blind, Placebo-controlled Study in Chinese Cardiacl Edema Patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group | Experimental |
| |
| median dose group | Experimental |
| |
| high dose group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003142 Injection | Drug | JMKX003142 injection for experimental groups once daily for five days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight | 5 days |
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Inclusion Criteria:
1) At least 40mg/day of furosemide equivalent loop diuretics; 2) Any dose of loop diuretics combined with thiazide diuretics; 3) Any dose of loop diuretics combined with aldosterone receptor antagonists or other potassium sparing diuretics.
5. After the background treatment in the run-in period, the subject still has the following two conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Zhang | Contact | +8618768467776 | zhangyang@jemincare.com |
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| ID | Term |
|---|---|
| D004489 | Edema, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D004487 | Edema |
| D012816 | Signs and Symptoms |
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| JMKX003142 Injection | Drug | JMKX003142 injection for experimental groups once daily for five days. |
|
| JMKX003142 Injection | Drug | JMKX003142 injection for experimental groups once daily for five days. |
|
| JMKX003142 placebo | Drug | JMKX003142 placebo for placebo groups once daily for five days. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |