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NCT01392469 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT01392469: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01392469 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01392469, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.
Primary Outcome
AUCtau was the area under the curve calculated to the end of the dosing interval, tau. The effect of co-administration of imatinib at two doses (200 and 400 mg) on the pharmacokinetics of bosentan was performed on dose normalized AUCtau of bosentan. A mixed effects linear model was fitted to the log-transformed PK parameters. This model included treatment (i.e., dose of imatinib) as a fixed effect, and participant as a random effect. Estimates for the treatment differences and associated 90% con
Interventions
- DRUG Bosentan
- DRUG Imatinib
- DRUG Sildenafil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-04-20 |
| Est. Completion | 2012-10-25 |
| Phase | Phase 3 |
What the finished NCT01392469 record still lists
NCT01392469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Bosentan is the first listed.
NCT01392469 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01392469 about?
NCT01392469 is a clinical study titled "Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants". The purpose of this study was to investigate the effects of QTI571 (imatinib) on pharmacokinetics of bosentan and sildenafil at steady state when co-administered to participants with pulmonary arterial hypertension.
What is the current status of trial NCT01392469?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2011-04-20. Estimated completion is 2012-10-25.
What interventions are being tested in trial NCT01392469?
The interventions under investigation include: Bosentan (DRUG), Imatinib (DRUG), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT01392469?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01392469's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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