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NCT01484431 · ClinicalTrials.gov registry record · Phase 1
A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension
A Phase 1 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01484431: Completed Phase 1 study, sponsored by Eli Lilly and Company.
NCT01484431 is a Phase 1 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01484431, a Phase 1 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
Primary Outcome
Population Pharmacokinetics: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau) for Tadalafil. The measure of dispersion reported is 90% Prediction Intervals and not Confidence Intervals.
Interventions
- DRUG Tadalafil- Tablet or Oral suspension
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-07-17 |
| Est. Completion | 2019-04-03 |
| Phase | Phase 1 |
What the finished NCT01484431 record still lists
NCT01484431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Tadalafil- Tablet or Oral suspension is the first listed.
NCT01484431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01484431 about?
NCT01484431 is a clinical study titled "A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension". The purpose of this study is to see how much study drug is in the blood of children with pulmonary arterial hypertension (PAH) after dosing to establish the correct dose for further clinical research.
What is the current status of trial NCT01484431?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-07-17. Estimated completion is 2019-04-03.
What interventions are being tested in trial NCT01484431?
The interventions under investigation include: Tadalafil- Tablet or Oral suspension (DRUG).
Who is sponsoring clinical trial NCT01484431?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01484431's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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