Pharmacokinetics and Pharmacdynamics of Sildenafil - Full Text View

Sponsors and Collaborators:	Children's Hospital of Philadelphia Clinical Translational Research Center at The Children's Hospital of Philadelphia
Information provided by:	Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:	NCT00718185

Purpose

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.

Condition	Intervention
Pulmonary Hypertension	Procedure: Obtain blood specimens

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Sildenafil citrate Sildenafil

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Biospecimen Description:

Blood specimens

Estimated Enrollment:	47
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A Patients receiving sildenafil as standard of care	Procedure: Obtain blood specimens Obtain blood samples at multiple timepoints.

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718185

Contacts

Contact: Athena Zuppa, MD, MSCE	215-590-5505	zuppa@email.chop.edu
Contact: Mary Ann DiLiberto, BS, RN	267-426-5753	diliberto@email.chop.edu

Locations

United States, Pennsylvania
The Children's Hospital of Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Ann DiLiberto, BS, RN 267-426-5753 diliberto@email.chop.edu
Sub-Investigator: Brian Hanna, MD
Sub-Investigator: Erin Reade, MD, MPH

Sponsors and Collaborators

Children's Hospital of Philadelphia

Clinical Translational Research Center at The Children's Hospital of Philadelphia

Investigators

Principal Investigator:

Athena Zuppa, MD

Children's Hospital of Philadelphia

More Information

Responsible Party:	The Children's Hospital of Philadelphia ( Athena Zuppa, MD, MSCE )
Study ID Numbers:	2007-11-5636
Study First Received:	July 16, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00718185
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:

Sildenafil
Pediatrics

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases

Vascular Diseases
Sildenafil
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009