NCT01417156 is a Phase 2 clinical trial of Nintedanib in Pulmonary Fibrosis, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT01417156?

NCT01417156 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT01417156?

Interventions in NCT01417156: Nintedanib, Pirfenidoneone.

What condition does NCT01417156 study?

NCT01417156 studies Pulmonary Fibrosis.

Is NCT01417156 still recruiting?

NCT01417156 is currently completed. Last updated 13 January 2017.

Are results published for NCT01417156?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-01-13 · How we verify

NCT01417156

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II Open Label, Follow up Study to Investigate the Long Term Tolerability and Safety of Oral BIBF 1120 on Top of Pirfenidone in Japanese Patients With Idiopathic Pulmonary Fibrosis

Completed Phase 2 Results posted Last updated 13 January 2017

What this trial tests

Phase 2 trial testing Nintedanib in Pulmonary Fibrosis in 20 participants. Completed in 1 October 2015.

Timeline

1 September 2011

Primary endpoint
1 October 2015

1 October 2015

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 September 2011
Primary completion	1 October 2015
Estimated completion	1 October 2015
Sites	4 locations across Japan

Drugs / interventions tested

Nintedanib (NINTEDANIB) — full drug profile →
Pirfenidoneone — full drug profile →

Conditions studied

Pulmonary Fibrosis — all drugs for Pulmonary Fibrosis →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

40 and older, any sex, with Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence of Overall Adverse Events
Time frame: First drug administration until end of treatment, up to 5 years
Incidence (Number of patients) of Adverse events (AEs) over the course of treatment period including serious adverse events (SAEs), AEs leading to discontinuation of study medication, and fatal AEs.

Sponsor's own description

Primary objective of this study is to investigate the long-term tolerability and safety profile of BIBF 1120 on top of pirfenidone treatment in patients with Idiopathic Pulmonary Fibrosis who have completed a prior clinical trial of BIBF 1120 (1199.31). Secondary objectives are to assess effects on some efficacy criteria during long term treatment with BIBF 1120 on top of pirfenidone.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Emerging delivery approaches for targeted pulmonary fibrosis treatment.
Diwan R, Bhatt HN, Beaven E, Nurunnabi M. · · 2024 · cited 52× · PMID 38065244 · DOI 10.1016/j.addr.2023.115147
Idiopathic pulmonary fibrosis: current treatment options and critical appraisal of nintedanib.
Bonella F, Stowasser S, Wollin L. · · 2015 · cited 38× · PMID 26715838 · DOI 10.2147/dddt.s76648
Reducing lung function decline in patients with idiopathic pulmonary fibrosis: potential of nintedanib.
Woodcock HV, Molyneaux PL, Maher TM. · · 2013 · cited 30× · PMID 23818761 · DOI 10.2147/dddt.s38833

Verify or expand the search:

Other trials of Nintedanib

Trials testing the same drug.

NCT07335562 — A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versu · Phase 3 · recruiting
NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis · Phase 3 · not yet recruiting
NCT06297096 — Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung Disease · Phase 3 · recruiting
NCT07015398 — A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in · Phase 1 · completed
NCT06643091 — Nintedanib Treatment in Unicentric Castleman Disease · Phase 2 · not yet recruiting

Other recruiting trials for Pulmonary Fibrosis

Currently open trials in the same condition.

NCT07464132 — Application of [68Ga]Ga-NI-FAPI-04 PET/CT Imaging in Fibroblast Activation Protein Related Diseases · Phase 1, PHASE2 · recruiting
NCT07396467 — Clinical Outcomes and Immunotherapy in Lung Cancer With Pulmonary Fibrosis · active not recruiting
NCT06912659 — The BALANCE Study: A Study in Spain to Find Out Whether a Patient Support Program Helps People With Pulmonary Fibrosis W · active not recruiting
NCT06685874 — Interstitial Lung Disease Exacerbations Study · active not recruiting
NCT06532071 — Advanced Imaging for Pulmonary Fibrosis · Phase 2 · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01417156 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 13 January 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01417156.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing