Pharmacokinetics and Pharmacdynamics of Sildenafil

This study has been terminated.
(Similar study completed.)
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00718185
First received: July 16, 2008
Last updated: February 22, 2010
Last verified: February 2010

July 16, 2008
February 22, 2010
May 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00718185 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetics and Pharmacdynamics of Sildenafil
The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood specimens

Non-Probability Sample

Infants, Children, and Adults receiving sildenafil as standard of care for the treatment of pulmonary hypertension.

Pulmonary Hypertension
Procedure: Obtain blood specimens
Obtain blood samples at multiple timepoints.
A
Patients receiving sildenafil as standard of care
Intervention: Procedure: Obtain blood specimens
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
February 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Receive enteral sildenafil as standard of care
  • > 28 days to >18 years of age
  • Informed consent/assent

Exclusion Criteria:

  • Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00718185
2007-11-5636
No
Athena Zuppa, MD, MSCE, The Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Athena Zuppa, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP