Pulmonary HypertensionNCT00718185
Pharmacokinetics and Pharmacdynamics of Sildenafil
An observational study of Pulmonary Hypertension, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Obtain blood specimens
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants, Children, and Adults receiving sildenafil as standard of care for the treatment of pulmonary hypertension.
Who may be able to join
- Receive enteral sildenafil as standard of care
- > 28 days to >18 years of age
- Informed consent/assent
Who cannot join
- Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients
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.
Read the 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.
- Conditions
- Pulmonary Hypertension
- Being tested
- Obtain blood specimens
- Keywords
- Sildenafil, Pediatrics
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obtain blood specimensProcedure or surgery
Obtain blood samples at multiple timepoints.
| Study group | Role | What they receive |
|---|---|---|
| A | Patients receiving sildenafil as standard of care Receives: Procedure: Obtain blood specimens |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension
Measured: 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.
Measured: Multiple time points throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionFeb 2010
Why it stopped: Similar study completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athena Zuppa, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718185
- Sponsor's protocol ID
- 2007-11-5636
- Status last verified
- Feb 2010
- First submitted
- 16 Jul 2008
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients
- ClinicalTrials.gov ID
- NCT00718185
- Acronym / sponsor ID
- 2007-11-5636
- Conditions
- Pulmonary Hypertension
- Keywords
- Sildenafil, Pediatrics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Similar study completed.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 18 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Procedure: Obtain blood specimensPatients receiving sildenafil as standard of care |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants, Children, and Adults receiving sildenafil as standard of care for the treatment of pulmonary hypertension.
Key inclusion criteria (3 listed)
- Receive enteral sildenafil as standard of care
- > 28 days to >18 years of age
- Informed consent/assent
Key exclusion criteria (1 listed)
- Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Obtain blood specimensObtain blood samples at multiple timepoints. | Procedure or surgery | A |
Primary outcome
To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension
Time frame: predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose
1 secondary outcome
To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension.
Time frame: Multiple time points throughout the study
Results and safety
The study was stopped early (reason given: Similar study completed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Athena Zuppa, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Similar study completed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension (time frame: predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2015.