A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure
Summary
A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure.
Timeline
- Start
- 2014-06-30
- Primary completion
- 2015-05-31
- Completion
- 2015-07-31
Outcome
Mixed primary results
registry MEAN Placebo: -0.17 (Standard Deviation 2.35) mm Hg NCT02157506 ↗
registry MEAN CXL-1427 5μg/kg/Min: -5.06 (Standard Deviation 3.93) mm Hg NCT02157506 ↗
registry analysis (superiority test); Placebo vs CXL-1427 5μg/kg/Min; p = 0.0001; Mixed Models Analysis NCT02157506 ↗
registry MEAN Placebo: -0.21 (Standard Deviation 3.35) mm Hg NCT02157506 ↗
registry MEAN CXL-1427 7μg/kg/Min: -2.67 (Standard Deviation 3.63) mm Hg NCT02157506 ↗
registry analysis (superiority test); Placebo vs CXL-1427 7μg/kg/Min; p = 0.1064; Mixed Models Analysis NCT02157506 ↗
registry analysis (superiority test); Placebo vs CXL-1427 3μg/kg/Min; p = 0.4241; Mixed Models Analysis NCT02157506 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | cimlanod | Other / unclassified | 3 ug/kg | Intravenous |