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. All rights document may not - in full or in part - be passed on, reproduced, published or otherwise used without prior written PAGEB oehringer Ingelheim28 Mar2017BI Trial No.: No.: c01765254-09 Trial ProtocolPage 2of 66 Proprietary confidential information.
with Idiopathic Pulmonary Fibrosis (IPF) Co-ordinating Investigator : Trialsites: Multi-centre, multi-national Clinical phase: III Objective: The primary objective of this study is to assess the long-term safety of BIBF 1120 treatment in patients with Idiopathic Pulmonary Fibrosis who have completed one
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