Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01619085 · ClinicalTrials.gov registry record · Phase 3
Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 752
- Enrollment target
NCT01619085: Completed Phase 3 study, sponsored by Boehringer Ingelheim.
NCT01619085 is a Phase 3 study that has completed, run by Boehringer Ingelheim. The registered enrollment target is 752 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01619085, a Phase 3 study, has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 752 participants
- Enrollment target
Study Summary
The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to continue treatment with BIBF 1120.
Primary Outcome
This is the measure for percentage of patients with adverse events (AEs) observed during the trial. The incidence of adverse events (% of patients) over the course of the trial, including the incidence of serious AEs, AEs leading to discontinuation, and fatal AEs are presented.
Interventions
- DRUG Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 752 participants |
| Start Date | 2012-06-06 |
| Est. Completion | 2021-02-01 |
| Phase | Phase 3 |
What the finished NCT01619085 record still lists
NCT01619085 is an interventional study that assigns participants to a tested intervention. The registered 752 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Nintedanib is the first listed.
NCT01619085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01619085 about?
NCT01619085 is a clinical study titled "Extension Trial of the Long Term Safety of BIBF 1120 in Patients With Idiopathic Pulmonary Fibrosis". The aim of this extension trial is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one year treatment and the follow up period in the double-blind phase III placebo controlled parent trials (1199.32 and 1199.34), who wish to con...
What is the current status of trial NCT01619085?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 752 participants. The study started on 2012-06-06. Estimated completion is 2021-02-01.
What interventions are being tested in trial NCT01619085?
The interventions under investigation include: Nintedanib (DRUG).
Who is sponsoring clinical trial NCT01619085?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01619085's enrollment target sits among peer trials
752 460th of 2000 higher than 1,539 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
- NCT06559306 · 752 participants · Phase 3
Phase 3 Study of Adjunctive Treatment With Seltorexant in Adult and Elderly Participants With Major Depressive Disorder and Insomnia Symptoms
- NCT05379985 · 754 participants · Phase 1
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
- NCT05427370 · 754 participants · NA
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
- NCT02048332 · 750 participants · Phase 1
Donor-Derived Viral Specific T-cells (VSTs)
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