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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
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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

Blood specimens


Enrollment: 9
Study Start Date: May 2008
Study Completion Date: February 2010
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

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Athena Zuppa, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Athena Zuppa, MD, MSCE, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00718185     History of Changes
Other Study ID Numbers: 2007-11-5636
Study First Received: July 16, 2008
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
Sildenafil
Pediatrics

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil
Vasodilator Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013