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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01096043 | A Dose-Defining Study of CXL-1020 in Patients With Systolic Heart Failure | PHASE2 | COMPLETED | 69 | — | — | Apr 1, 2010 | Feb 1, 2012 | Nov 15, 2016 | 15 | United States |
Define the safety and hemodynamic benefit of CXL-1020 based upon the change from baseline in hemodynamic measurements at the 6 hour time point in all strata
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Each Strata of the study will have a placebo control. In strata A, the chance of getting active drug is 4 out of 5, in Strata B the chance of getting active drug is 3 ot of 4, and in Strata C, the chance of getting active Drug is 4 out of 5. In the event that a patient is allocated to receive placebo, the treatment may be stopped if the patient's condition fails to improve or worsens during the placebo infusion. |
| Strata 1 CXL-1020 | EXPERIMENTAL | Patients assigned to CXL-1020 in strata one will have their dose increased from the initial dose 2 times during the study period. The treatment may be stopped if the patient's condition fails to improve or worsens during the infusion. |
| Strata 2 CXL-1020 | EXPERIMENTAL | In strata 2, patients who are assigned to active treatment will receive one of up to 3 possible fixed dose levels of CXL-1020 for a period of 6 hours. The treatment may be stopped if the patient's condition fails to improve or worsens during the infusion. |
| Strata 3 CXL-1020 | EXPERIMENTAL | In strata 3, patients assigned to receive CXL-1020 will receive a fixed dose of CXL-1020 for 6 hours, and then the dose may be increased or decreased, based on the investigators assessment of the patient. The treatment may be stopped if the patient's condition fails to improve or worsens during the infusion. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | An infusion of an identically appearing solution of sugar water will be intravenously administered. |
| Strata 1 CXL-1020 | DRUG | Intravenous infusion of CXL-1020, up-titrated, so that 3 different dosages are administered over 6 hours |
| Strata 2 CXL-1020 | DRUG | One of 3 different dosages of CXL-1020 administered at a fixed dosage level for 6 hours. |
| Strata 3 CXL-1020 | DRUG | A fixed dose level of CXL-1020 will be administered for the initial 6 hours of treatment in Strata 3 and then dosage will be altered up or downward based on the investigators observation of the patient's condition. |
Inclusion Criteria: In order to be eligible for randomization, a patient MUST: * Be a male or post menopausal or surgically sterile female requiring inpatient evaluation or treatment and be between 18 and 85 years of age * Not require immediate emergent treatment with conventional parenteral inotr...