Nycomed is committed to being transparent about clinical trials we sponsor. We recognise that there are important public health benefits to making clinical trial information available.
Our commitment to register clinical trials is based on the requirements outlined in the
Declaration of Helsinki (2008) of the World Medical Association, and the Joint position paper (2010) of the International Federation of Pharmaceutical Manufacturers and Associations. These documents were updated in October and November 2008, respectively. Nycomed also adheres to the Food and Drug Administration Amendments Act (FDAAA) of 2007.
Clinical registration
We publish clinical trials in phases I-IV on our Products on the publicly accessible
clinical trial registry. Clinical trials are registered before enrolment of first subject.
Clinical trial results disclosure
Regardless of outcome Nycomed discloses results of all clinical trials (phase I-IV) on marketed products. We disclose the results in the publicly accessible clinical trials results database (see www.clinicaltrials.gov and www.clinicalstudyresults.org).
We post results within one year after the product is first approved and sold in any country, unless the posting would compromise publication in a peer-reviewed journal or contravene national laws and regulations.
We comply with the FDAAA and publish trial results within 30 days after FDA’s decision on license application in the US.
Link to Nycomed clinical trials
Search Nycomed clinical trials at clinicaltrials.gov.
Some Nycomed trials were initiated by Altana Pharma, and remain registered under that name. Search those here.