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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01979614 | Study of the Vascular Effects of Serelaxin | PHASE2 | COMPLETED | 58 | — | — | Feb 3, 2014 | Aug 17, 2016 | Jul 1, 2019 | 3 | United Kingdom |
Global MPRI (Myocardial Perfusion Reserve Index) is defined as ratio between mean global myocardial blood flow values at rest and during adenosine stress with Mid Perfusion Reserve Index or Midl PRI (Mid Perfusion Reserve Index) which is defined as ratio between mid myocardial blood flow values at rest and during adenosine stress
| Arm | Type | Description |
|---|---|---|
| Serelaxin | EXPERIMENTAL | Serelaxin was administered at a dose of 30 μg/kg/24h by intravenous infusion for 48 hours |
| Placebo | PLACEBO_COMPARATOR | Placebo was administered by intravenous infusion for 48 hours |
| Name | Type | Description |
|---|---|---|
| Serelaxin | DRUG | Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution |
| Placebo | OTHER | 5% v/v glucose solution |
Inclusion Criteria: * Male and female patients ≥18 years of age, with body weight \<160 kg. * Patients with proven obstructive coronary artery disease, determined either by functional (e.g. treadmill testing) or non-invasive clinical imaging assessments (e.g. stress-echo, PET or SPECT myocardial pe...