Transcription of Clinical Trial Protocol
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Clinical Trial Protocol
Clinical Trial ProtocolDoc. No.: c01765254-09 EudraCT No.:BI Trial No. InvestigationalProduct:BIBF 1120 (nintedanib)Title:An open-labelextension trialof the long term safety of oral BIBF1120 in patients with Idiopathic Pulmonary Fibrosis(IPF) Clinical Phase:IIIT rial Clinical Monitor:Phone : Fax: Co-ordinating Investigator:Phone: Fax: Status:Final Protocol (Revised Protocol (based on Global Amendment 3))Version and Date: :28 Mar2017 Page 1 of 66 Proprietary confidential information. 2017 Boehringer Ingelheim International GmbH or one or more of its affiliated companies.
clinical trial) are required to sign an informed consent explaining the objective and study related procedures of the trial after the final analysis. This should happen prior to any study related activities of this new trial period. 3. Same scheme should be repeated as often as needed: one visit every 16 weeks. 4.
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