Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Strata 1 CXL-1020 · 1 trial · 1 indication
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...
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Strata 1 CXL-1020 is an investigational small molecule being developed for the treatment of heart failure. It is a cardiovascular therapeutic that has been studied in patients with systolic heart failure. The drug is not approved and remains in clinical development.
Strata 1 CXL-1020 is a small molecule designed for cardiovascular use, specifically in heart failure. Its molecular target has not been disclosed in available information, so its precise mechanism of action is not specified.
Strata 1 CXL-1020 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research on this investigational drug for heart failure.
Strata 1 CXL-1020 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is no longer in active clinical testing.
Strata 1 CXL-1020 was studied in a completed Phase 2 clinical trial registered as NCT01096043, titled "A Dose-Defining Study of CXL-1020 in Patients With Systolic Heart Failure." The trial enrolled 69 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Strata 1 CXL-1020 is also known as CXL-1020. The drug is referred to by both names in clinical research, with the trial NCT01096043 using the name CXL-1020 in its title.