Pharmacokinetics and Pharmacdynamics of Sildenafil | NCT00718185

Studies
Pharmacokinetics and Pharmacdynamics of Sildenafil

NCT00718185

Sponsor

Children's Hospital of Philadelphia

Status

Terminated

Last Update Posted

Mar 12, 2015Estimated

Enrollment

9Actual

Phase

Not provided

Conditions

Pulmonary Hypertension

Interventions

Obtain blood specimens

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Similar study completed.

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Jul 16, 2008

First Submission Date that Met QC Criteria

Jul 17, 2008

First Posted Date

Jul 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2015

Last Update Posted Date

Mar 12, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		Patients receiving sildenafil as standard of care	Procedure: Obtain blood specimens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Obtain blood specimens	Procedure	Obtain blood samples at multiple timepoints.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Athena Zuppa, MD	Children's Hospital of Philadelphia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Children's Hospital of Philadelphia		Philadelphia	Pennsylvania	19104	United States

Condition Browse Module

MeSH Terms

ID	Term
D006976	Hypertension, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006973	Hypertension
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided