Pharmacokinetics and Pharmacdynamics of Sildenafil

Terminated

• Conditions: Pulmonary Hypertension
• Interventions: Procedure: Obtain blood specimens

• Registration Number: NCT00718185
• Lead Sponsor: Children's Hospital of Philadelphia

Brief Summary

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.

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-17
• Study First Posted: 2008-07-18
• Primary Completion: 2009-12
• Status Verified: 2010-02
• Study Completion: 2010-02
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Obtain blood specimens	Patients receiving sildenafil as standard of care

Primary Outcome Measures

Name	Time	Method
To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension	predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose

Secondary Outcome Measures

Name	Time	Method
To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension.	Multiple time points throughout the study

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States