Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)

Inclusion criteria:

1. Written Informed Consent consistent with International Conference on Harmonisation
Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study

2. Patient aged >= 40 years at Visit 1.

3. IPF diagnosed, according to the 2011 ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and
management, within 5 years and reaffirmed applying 2011 Guidelines (P11-07084) if
diagnosed >2 years and up to 5 year from Visit 1,. Diagnosis must be confirmed by
chest HRCT taken within 24 months of Visit 1. All HRCT results reported to be possible
or inconsistent usual interstitial pneumonia (UIP) must have confirmatory pathology.

4. DLCO (corrected for Hb): 30%-79% predicted of normal

5. FVC >= 50% predicted of normal at Visit 1 and Visit 2

Exclusion criteria:

1. AST, ALT > 1.5 fold ULN

2. Bilirubin > 1.5 fold ULN

3. Bleeding risk:

1. Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g.
vitamin K antagonists, dabigatran, heparin, hirudin), or high dose antiplatelet
therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for
maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 IU s.c. per
day) and prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up
to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet
therapy)

2. History of hemorrhagic Central Nervous System (CNS) event within 12 months

3. Any of the following within 3 months:

- Haemoptysis or haematuria.

- Active gastro-intestinal bleeding or ulcers.

- Major injury or surgery.

4. Coagulation parameters: International normalised ratio (INR) > 2, prothrombin
time (PT) and partial thromboplastin time (PTT) > 150% of institutional ULN.

4. Planned major surgery within the next 3 months, including lung transplantation, major
abdominal or major intestinal surgery.

5. Thrombotic risk

1. Known inherited predisposition to thrombosis.

2. History of thrombotic event (including stroke and transient ischemic attacks)
within 12 months

6. Current or planned usage of any investigational drug during the course of this trial

7. Previous treatment with nintedanib within a clinical trial in the previous 3 months
and discontinuation of nintedanib study treatment due to an adverse event

8. Known hypersensitivity to the trial drug or its component

9. A disease or condition which in the opinion of investigator may put the patient at
risk because of participation in this trial or limit the patient's ability to
participate in this trial. Patients will be excluded if they require greater than
12L/min oxygen, are not ambulatory or require use of a walker or cane during the 6
Minute Titration Walk Test. Patients who cannot complete the 6 Minute Titration Walk
Test are excluded from participation.

10. Alcohol or drug abuse which in the opinion of the investigator would interfere with
trial participation.

11. Pregnant women or women who are breast feeding or of child bearing potential not using
two effective methods of birth control (one barrier and one highly effective
non-barrier) for at least 1 month prior to trial and/or not committing to using it
until 3 months after end of treatment.