Pharmacokinetics and Pharmacdynamics of Sildenafil

Pulmonary Hypertension Clinical Trial

Official title:

The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718185
• Other study ID #: 2007-11-5636
• Status: Terminated
• Phase: N/A
• First received: July 16, 2008
• Last updated: March 11, 2015
• Start date: May 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• Obtain blood specimens
Obtain blood samples at multiple timepoints.

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No