Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01338415 · ClinicalTrials.gov registry record · Phase 3
FUTURE 3 Study Extension
A Phase 3 study, sponsored by Actelion.
- Completed
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT01338415: Completed Phase 3 study, sponsored by Actelion.
NCT01338415 is a Phase 3 study that has completed, run by Actelion. The registered enrollment target is 58 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01338415, a Phase 3 study, has completed, sponsored by Actelion.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study Summary
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
Primary Outcome
This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
Interventions
- DRUG Bosentan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2011-03-08 |
| Est. Completion | 2020-05-29 |
| Phase | Phase 3 |
What the finished NCT01338415 record still lists
NCT01338415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Bosentan is the first listed.
NCT01338415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01338415 about?
NCT01338415 is a clinical study titled "FUTURE 3 Study Extension". The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
What is the current status of trial NCT01338415?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2011-03-08. Estimated completion is 2020-05-29.
What interventions are being tested in trial NCT01338415?
The interventions under investigation include: Bosentan (DRUG).
Who is sponsoring clinical trial NCT01338415?
This trial is sponsored by Actelion, which has 63 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01338415's enrollment target sits among peer trials
58 1825th of 2000 higher than 174 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03587844 · 58 participants · Phase 2
Dosing of Brentuximab Vedotin for Mycosis Fungoides, Sezary Syndrome Patients
- NCT03630991 · 58 participants · Phase 1
Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy
- NCT03949855 · 58 participants · Phase 2
Belimumab With Rituximab for Primary Membranous Nephropathy
- NCT04069273 · 58 participants · Phase 2
Novel SEQUEnced Immunotherapy With Anti-angiogenesis and Chemotherapy in Advanced gastroesophageaL Adenocarcinoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI