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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01092325 | Safety and Hemodynamic Effects and Pharmacokinetics of CXL-1020 in Patients With Stable Heart Failure | PHASE1 | COMPLETED | 28 | — | — | Jun 1, 2009 | May 1, 2010 | Jul 1, 2016 | 1 | United States |
Safety is measured by assessment of multiple parameters including standard laboratory safety, changes in blood pressure and heart rate, changes in electrocardiogram, monitoring of heart rhythm via holter monitor, measurement of cardiac safety biomarkers such as plasma troponin as well as treatment emergent adverse events
| Arm | Type | Description |
|---|---|---|
| Cohort 1 CXL-1020 | EXPERIMENTAL | An intravenous infusion of CXL-1020 administered for a total of 4 hours over a total of 3 occasions separated by at least one week. Each of the 3 doses of CXL-1020 are different, starting with the lowest dose and increasing to the highest dose. |
| Cohort 1 Placebo | PLACEBO_COMPARATOR | A 4 hour infusion of Placebo administered one time randomly among the 3 active doses of CXL-1020 in cohort 1 |
| Cohort 2 CXL-1020 | EXPERIMENTAL | An intravenous infusion of CXL-1020 administered for a total of 4 hours over a total of 3 occasions separated by at least one week. Each of the 3 doses of CXL-1020 are different, starting with the lowest dose and increasing to the highest dose. |
| Cohort 2 Placebo | PLACEBO_COMPARATOR | A 4 hour infusion of Placebo administered one time randomly among the 3 active doses of CXL-1020 in cohort 1 |
| Echo Cohort A CXL-1020 | ACTIVE_COMPARATOR | A 4 hour infusion of a fixed dose of CXL-1020 which was studied in Cohort 1 or Cohort 2 which is expected to be well tolerated and have hemodynamic effect |
| Echo Cohort B CXL-1020 | ACTIVE_COMPARATOR | CXL-1020 administered at a fixed rate for the initial 2 hours and at a higher fixed rate for the last 2 hours of a 4 hour infusion at doses which were studied in Cohort 1 or Cohort 2 and expected to be well tolerated and have hemodynamic effects |
| Name | Type | Description |
|---|---|---|
| CXL-1020 | DRUG | Intravenous infusion of one of 3 active dosages of CXL-1020 |
| Placebo for CXL-1020 Cohort 1 | DRUG | A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water) |
| Placebo for CXL-1020 Cohort 2 | DRUG | A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water) |
| CXL-1020 Dose for Echo Cohort A | DRUG | A 4 hour fixed dose of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect |
| CXL-1020 Doses for Echo Cohort B | DRUG | A 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect followed by another higher 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect |
Inclusion Criteria: In order to be eligible for randomization, a patient MUST: * Be a male or post menopausal or surgically sterile female outpatient between 18 and 85 years of age * Have chronic Systolic HF due to primary/idiopathic dilated cardiomyopathy, coronary artery disease or hypertension,...