Pharmacokinetics and Pharmacdynamics of Sildenafil
This study has been terminated.
(Similar study completed.)
Sponsor:
Children's Hospital of Philadelphia
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00718185
First received: July 16, 2008
Last updated: February 22, 2010
Last verified: February 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 16, 2008 | ||||
| Last Updated Date | February 22, 2010 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00718185 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pharmacokinetics and Pharmacdynamics of Sildenafil | ||||
| Official Title ICMJE | The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Blood specimens |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Infants, Children, and Adults receiving sildenafil as standard of care for the treatment of pulmonary hypertension. |
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| Condition ICMJE | Pulmonary Hypertension | ||||
| Intervention ICMJE | Procedure: Obtain blood specimens
Obtain blood samples at multiple timepoints. |
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| Study Group/Cohort (s) | A
Patients receiving sildenafil as standard of care
Intervention: Procedure: Obtain blood specimens |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 9 | ||||
| Completion Date | February 2010 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00718185 | ||||
| Other Study ID Numbers ICMJE | 2007-11-5636 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Athena Zuppa, MD, MSCE, The Children's Hospital of Philadelphia | ||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||
| Verification Date | February 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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