Pharmacokinetics and Pharmacdynamics of Sildenafil

NCT ID: NCT00718185

Last Updated: 2015-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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A

Patients receiving sildenafil as standard of care

Obtain blood specimens

Intervention Type PROCEDURE

Obtain blood samples at multiple timepoints.

Interventions

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Obtain blood specimens

Obtain blood samples at multiple timepoints.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Athena Zuppa, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

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The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2007-11-5636

Identifier Type: -

Identifier Source: org_study_id

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