Pharmacokinetics and Pharmacdynamics of Sildenafil
The study is being done to investigate what happens to sildenafil in the body and how long it takes to get rid of this drug. Understanding how long the drug stays in the body and how it is changed by the body will help doctors determine the best dose. We also want to learn how well the medicine works based on the size of the dose or amount in the bloodstream.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients|
- To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension [ Time Frame: predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose ] [ Designated as safety issue: No ]
- To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension. [ Time Frame: Multiple time points throughout the study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
|Study Start Date:||May 2008|
|Study Completion Date:||February 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Patients receiving sildenafil as standard of care
Procedure: Obtain blood specimens
Obtain blood samples at multiple timepoints.
There is no data regarding sildenafil drug disposition in infants and children with pulmonary hypertension. Sildenafil is used at The Children's Hospital of Philadelphia for the treatment of pulmonary hypertension. Patients receiving sildenafil as standard of care will be approached for consent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718185
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Athena Zuppa, MD||Children's Hospital of Philadelphia|