Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01870778 | Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF | PHASE3 | COMPLETED | 6,600 | — | — | Oct 2, 2013 | Feb 1, 2017 | Mar 30, 2018 | 540 | United States, Argentina +33 |
| NCT01543854 | Hemodynamic Responses to RLX030 Infusion in Subjects With Acute Heart Failure | PHASE2 | COMPLETED | 71 | — | — | Mar 1, 2012 | Jan 1, 2013 | Aug 5, 2014 | 20 | Argentina, Germany +4 |
The percentage of participants with an adjudicated CV death through day 180 was assessed.
The percentage of participants with WHF through day 5 was assessed.
Measurements will be made using a Swan-Ganz indwelling catheter
Measurements will be made using a Swan-Ganz indwelling catheter
| Arm | Type | Description |
|---|---|---|
| Serelaxin (RLX030) | EXPERIMENTAL | Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours. |
| Placebo | PLACEBO_COMPARATOR | Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours. |
| RLX030 | EXPERIMENTAL | RLX030 as intravenous infusion for 20 hours |
| Name | Type | Description |
|---|---|---|
| RLX030 | DRUG | 1 mg/mL solution in 6 mL vials |
| Placebo | DRUG | Matching placebo solution to serelaxin |
Key Inclusion Criteria: * Male or female 18 years of age, with body weight ≤160 kg * Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department)...