Pharmacokinetics and Pharmacdynamics of Sildenafil

March 11, 2015 updated by: Children's Hospital of Philadelphia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Patients receiving sildenafil as standard of care
Procedure: Obtain blood specimens
Obtain blood samples at multiple timepoints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Multiple time points throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Athena Zuppa, MD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

July 17, 2008

First Posted (Estimate)

July 18, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2015

Last Update Submitted That Met QC Criteria

March 11, 2015

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-11-5636

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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