Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sestamibi · 1 trial · 1 indication
The proportion of all patients who experienced cardiac events among patients with abnormal (SSS \>=4, high risk) and normal (SSS \<4, low risk) Cardiolite MPI scans during the follow-up period. A log-rank statistic (2-sided, alpha = 0.05) was computed to compare cardiac event-free survival in the high risk and low risk groups. The cardiac event rate is the cumulative event rate based on a Kaplan-Meier estimate conditional on the SPECT MPI score result.
| Arm | Type | Description |
|---|---|---|
| Children (Ages 4-11) | OTHER | Children 4-11 years of age, intervention Sestamibi |
| Adolescents (Ages 12-16) | OTHER | Adolescents 12-16 years of age, intervention Sestamibi |
| Name | Type | Description |
|---|---|---|
| Sestamibi | DRUG | Sestamibi |
Inclusion Criteria: * Males or females between 4 and 16 * Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician. * Be able to exercise adequately to achieve 85% age predicted maxim...
Sestamibi is a small molecule being studied for use in Kawasaki Disease. It is being evaluated in pediatric patients to assess its use and safety. The drug is currently in Phase 3 clinical development, though the specific therapeutic application in this condition is not detailed beyond the trial context.
Sestamibi is developed by Lantheus Holdings, Inc., a company traded under the ticker LNTH. The company is conducting clinical research on this drug for Kawasaki Disease, with the drug being investigated in a Phase 3 trial.
Sestamibi is in Phase 3 clinical development for Kawasaki Disease. It is an investigational drug, meaning it has not been approved for this use. The Phase 3 trial has been completed, with a total enrollment of 445 participants.
Sestamibi has one completed Phase 3 trial, NCT00162032, titled 'A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease.' This trial enrolled 445 participants across multiple countries, including the United States, Brazil, Canada, Philippines, South Korea, Taiwan, and Thailand.
Yes, Sestamibi is also known as CARDIOLITE, as referenced in the clinical trial title. The trial NCT00162032 evaluates the use and safety of CARDIOLITE in pediatric patients with Kawasaki Disease, indicating that these names refer to the same drug.