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| ID | Type | Description | Link |
|---|---|---|---|
| MK7418-201 |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
A study to determine the most appropriate dose of MK7418 in heart failure patients presenting with symptoms of volume overload requiring increased diuretic doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | rolofyline 2.5 mg IV QD |
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| 2 | Experimental | rolofyline 15 mg IV QD |
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| 3 | Experimental | rolofyline 30 mg IV QD |
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| 4 | Experimental | rolofyline 60 mg IV QD |
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| 5 | Placebo Comparator | placebo for rolofyline IV QD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rolofyline | Drug | rolofyline 2.5 mg IV QD; 15 mg IV QD; 30 mg IV QD; 60 mg IV QD; 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| To measure the diuretic effect of a single dose of the study medication (monotherapy) over six hours compared to a single dose of IV placebo (monotherapy) in CHF patients with renal impairment | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the optimal dose range of intravenous (IV) study medication combination with IV furosemide, with or without other diuretics, in preventing deterioration of renal function in CHF patients | 30 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| C073525 | rolofylline |
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| Comparator Placebo (unspecified) | Drug | Matching placebo for rolofyline IV QD; 3 days |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |