Trials / Completed
CompletedNCT01670136
Pharmacokinetics of Sildenafil in Premature Infants
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 364 Days
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to learn more about the safety and dosing of sildenafil in infants.
Detailed description
Pharmacokinetics and safety of sildenafil will be studied in preterm infants who are receiving sildenafil per standard of care or 1 dose prescribed for the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 1 dose of sildenafil | A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg. |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2012-08-21
- Last updated
- 2016-11-02
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01670136. Inclusion in this directory is not an endorsement.