In addition to sharing technical results summaries on clinicaltrials.gov and eudract.ema.europa.eu (EudraCT), Amgen has committed to publicly disclose a synopsis of each clinical study report (CSR Synopsis) for Amgen-sponsored trials included in the marketing application beginning with new product approvals in 2015.
Synopses for clinical trials submitted in marketing applications for new Amgen products and indications in the US and EU since 2014 are posted within 90 days after regulatory approval in the region with the later approval. For subsequent marketing applications in other countries, synopses for additional studies conducted to support these approvals are posted after the respective approvals.
Synopses are also available for clinical trials in patients (and for selected non-interventional studies) back to 2004, for approved products and indications or for programs where development has discontinued.
The CSR synopses are redacted to remove commercially confidential or personally identifying patient information before posting on AmgenTrials.com.
This information is intended to satisfy public disclosure commitments and shall not be used for any other purpose. It shall also not be considered to be a claim for any marketed product. Some information in this document may differ from, or not be included in, the approved labeling for the product. Please refer to the full prescribing information for indications and proper use of the product.
To locate the CSR synopsis for a particular clinical trial, please click on the name of the product of interest below. You will be taken to a list of clinical trials by product from where you can select the particular clinical trial of interest by the study number and title. Please note the list of products will be visible as the CSR synopses are made available.Product List