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Pharmacokinetics and Pharmacdynamics of Sildenafil

This study has been terminated.
(Similar study completed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00718185
First Posted: July 18, 2008
Last Update Posted: March 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
  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:


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 ]

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 ]

Biospecimen Retention:   Samples Without DNA
Blood specimens

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00718185     History of Changes
Other Study ID Numbers: 2007-11-5636
First Submitted: July 16, 2008
First Posted: July 18, 2008
Last Update Posted: March 12, 2015
Last Verified: February 2010

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

Additional relevant MeSH terms:
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents