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Dexmedetomidine · 1 trial · 3 indications
The occurrence of any of the following that is possibly, probably, or definitely related to DEX administration: * Bradycardia * Heart block * Junctional rhythm * Hypotension * Excessive sedation * Cardiac arrest or ECMO cannulation * Serious Adverse Event (SAE) Both the DEX dose, and DEX exposure will be assessed for associations with the primary outcome.
| Arm | Type | Description |
|---|---|---|
| Neonate dosing cohort 1 | EXPERIMENTAL | Neonate dexmedetomidine dosing cohort 1 |
| Neonate dosing cohort 2 | EXPERIMENTAL | Neonate dexmedetomidine dosing cohort 2 |
| Neonate dosing cohort 3 | EXPERIMENTAL | Neonate dexmedetomidine dosing cohort 3 |
| Neonate dosing cohort 4 | EXPERIMENTAL | Neonate dexmedetomidine dosing cohort 4 |
| Neonate dosing cohort 5 | EXPERIMENTAL | Neonate dexmedetomidine dosing cohort 5 |
| Infant dosing cohort 1 | EXPERIMENTAL | Infant dexmedetomidine dosing cohort 1 |
| Infant dosing cohort 2 | EXPERIMENTAL | Infant dexmedetomidine dosing cohort 2 |
| Infant dosing cohort 3 | EXPERIMENTAL | Infant dexmedetomidine dosing cohort 3 |
| Infant dosing cohort 4 | EXPERIMENTAL | Infant dexmedetomidine dosing cohort 4 |
| Infant dosing cohort 5 | EXPERIMENTAL | Infant dexmedetomidine dosing cohort 5 |
| Name | Type | Description |
|---|---|---|
| Dexmedetomidine | DRUG | - |
Inclusion Criteria: 1. Male or female, age 0 to 180 days at the time of surgery. 2. Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent du...
Dexmedetomidine is an investigational small molecule being studied for use in Transposition of the Great Arteries, a congenital heart condition. It is being evaluated in the setting of corrective infant cardiac surgery, where it is given as a bolus and infusion to assess its safety and pharmacokinetics.
Dexmedetomidine is a small molecule that acts as a selective alpha-2 adrenergic receptor agonist. By binding to these receptors, it produces sedative, analgesic, and anxiolytic effects, which are relevant in the perioperative setting for infant cardiac surgery.
Dexmedetomidine is being developed by Elevance Health, Inc., a company traded on the New York Stock Exchange under the ticker symbol ELV. The company is conducting clinical research to evaluate the drug's safety and pharmacokinetics in pediatric cardiac surgery patients.
Dexmedetomidine is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacokinetic profile in the studied population.
Dexmedetomidine has one completed clinical trial, identified as NCT01915277, titled "A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics." The trial enrolled 119 participants and was conducted in the United States.
Dexmedetomidine is a distinct drug entity and is not known to be the same as other marketed medications. It is a selective alpha-2 adrenergic agonist used in research settings for its sedative properties, particularly in the context of pediatric cardiac surgery.