Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective is to evaluate the efficacy and safety on the tolvaptan for increasing serum Na levels in patients with worsening heart failure and hyponatremia.
This is a phase 4, multicenter, randomized, double-blind, placebo-controlled, parallel-group interventional study comparing tolvaptan (15 to 60 mg) to placebo in adult patients hospitalized (or admission to emergency room) due to worsening of heart failure and dilutional hyponatremia. All patients will be on standard therapy for heart failure.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tolvaptan | Experimental | Tovaptan tablet 15mg, 30mg, 60mg, once a day, oral |
|
| placebo | Placebo Comparator | placebo tablet 15mg, 30mg, 60mg, once a day, oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolvaptan | Drug | Start with 15mg to titrate upwards to 30mg to 60mg, once a daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average daily AUC of change from baseline in serum Na level to day 4 within the double-blind treatment period | from baseline to day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Average amount of furosemide used during hospitalization. | from day 1 to discharge date (up to subject condition day 2 ~ day 30) | |
| Average amount of furosemide used during out-patient period. | from baseline to day 30 and day 60 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dongju Choi, MD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seoul | South Korea |
Not provided
| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Start with 15mg to titrate upwards to 30mg to 60mg, once a daily |
|