What will happen during this study?
If you agree to participate in this study, you will be randomly assigned (like the flip on a coin) to receive either nintedanib or placebo. You have an equal chance of receiving either study drug.
You will take your study drug twice a day for at least 52 weeks. It is possible you may be asked to continue taking your study drug until all patients in the study have completed their treatment.
This means your total study participation could last 1.5 to 2 years. You will also visit the study clinic approximately 11 to 14 times throughout the study to undergo tests and assessments to monitor your health.
What are the risks and benefits related to this study?
As with any research study, there is no guarantee that the investigational drug will help you. It is also possible you could experience one or more side effects. Some of the very common side effects of nintedanib include diarrhea, nausea, abdominal pain, and abnormal liver test results. The study staff will review the full list of side effects with you before you decide whether or not to join the study.
Your health and safety will be monitored while you are in this study. The sponsor of this study was required to design a protocol, which explains all study procedures in detail. An independent review board responsible for participant safety reviewed this protocol and requires that it be followed exactly.