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Clinical Trial Summary

This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy


Clinical Trial Description

This pregnancy registry will be conducted by University of California Research Center for the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout North America. Participants will be enrolled on an ongoing basis through year 10 of the study and each will be followed from the time they enroll, through the 5-year postnatal follow up period for an overall study period of 15 years. Participants are recruited concurrently from callers to OTIS centers, from healthcare providers and through direct to consumer marketing efforts. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02957604
Study type Observational [Patient Registry]
Source Amgen
Contact
Status Terminated
Phase
Start date December 22, 2016
Completion date September 2, 2020