Pharmacokinetics and Pharmacdynamics of Sildenafil

NCT00718185 | Terminated

• 1 other identifier: 2007-11-5636
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Sildenafil; Pediatrics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

A

Patients receiving sildenafil as standard of care

Procedure: Obtain blood specimens

Interventions

Obtain blood specimens PROCEDURE

Obtain blood samples at multiple timepoints.

A

Eligibility Criteria

• Age: 28 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Receive enteral sildenafil as standard of care
• \> 28 days to \>18 years of age
• Informed consent/assent

You may not qualify if:

• Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood specimens

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Athena Zuppa, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 12, 2015

Record last verified: 2010-02

Locations

US (1)