Angiotensin II receptor blockers and risk of cancer after contamination with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) (Sartans contamination -feasibility study)

Study identification

• EU PAS number:
  EUPAS31895
• Study ID:
  31896
• Official title and acronym:
  Angiotensin II receptor blockers and risk of cancer after contamination with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) (Sartans contamination -feasibility study)
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  This is a feasibility analysis to inform a potential epidemiological study of an association between exposure to contaminated sartans products and the occurrence of cancer. The study will calculate sample sizes needed to detected the estimated cancer risk and minimum excess risk, as well as identifying EU databases with enough information to allow the conduct of the study.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 01/09/2018

Actual: 01/09/2018

Study start date

Planned: 15/09/2018

Actual: 15/09/2018

Date of final study report

Planned: 11/02/2019

Actual: 11/02/2019

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable