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NCT01824290 · ClinicalTrials.gov registry record · Phase 3
A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT01824290: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT01824290 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 35 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01824290, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 year extension period (Period 2) during which participants will receive tadalafil.
Primary Outcome
6MWD in meters assessed in a subset of participants who are ≥6 to \<18 years of age who are developmentally capable of performing a 6MW test. Change from baseline was derived using mixed model repeated measures (MMRM) with terms for treatment group, visit, baseline 6MWD, and treatment-by-visit interaction.
Interventions
- DRUG Placebo
- DRUG Tadalafil
- DRUG ERA as specific PAH treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2014-02-05 |
| Est. Completion | 2021-03-10 |
| Phase | Phase 3 |
What the finished NCT01824290 record still lists
NCT01824290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01824290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01824290 about?
NCT01824290 is a clinical study titled "A Study of Tadalafil in Pediatric Participants With Pulmonary Arterial Hypertension (PAH)". The main purpose of this study is to evaluate the safety and efficacy of tadalafil in pediatric participants with pulmonary arterial hypertension. Participants will receive study treatment for 6 months in the double-blind period (Period 1), and then will be eligible to enroll into an open-label 2 ye...
What is the current status of trial NCT01824290?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2014-02-05. Estimated completion is 2021-03-10.
What interventions are being tested in trial NCT01824290?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG), ERA as specific PAH treatment (DRUG).
Who is sponsoring clinical trial NCT01824290?
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 NCT01824290's enrollment target sits among peer trials
35 1903rd of 2000 higher than 96 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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