Status: Ongoing First registered on: 16/03/2017
Last updated on: 11/10/2018
1. Study identification
EU PAS Register NumberEUPAS18201
Official titleUnited States Post-Marketing Observational Cardiovascular Safety Study in Patients taking Naloxegol
Study title acronymNaloxegol US Post-Market Requirement CV Safety
Study typeObservational study
Brief description of the studyThe overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically.
Was this study requested by a regulator?Yes: United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableD3820R00008
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsEvidera
Department/Research group
Organisation/affiliationEvidera
Website/Homepagewww.evidera.com
Details of (Primary) lead investigator
Title Dr
Last name Wittbrodt
First name Eric
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2
HealthCore, United States
Edward Hines Jr. VA Hospital, United States
Chicago Association for Research and Education in Science, United States
Scott & White Memorial Hospital, United States
Countries in which this study is being conducted
National study

United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/10/201513/10/2015
Start date of data collection01/12/201501/12/2015
Start date of data analysis01/06/201601/06/2016
Date of interim report, if expected30/06/201823/05/2018
Date of final study report31/12/2023
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAstraZeneca100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Wittbrodt
First name Eric
Address line 11800 Concord Pike
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com
Public Enquiries
Title Dr 
Last name AstraZeneca 
First name Clinical Study Information Center 
Address line 11800 Concord Pike 
Address line 2PO Box 15437 
Address line 3 
CityWilmington, De 
Postcode19850 
CountryUnited States 
Phone number (incl. country code)0018772409479 
Alternative phone number 
Fax number (incl. country code) 
Email address information.center@astrazeneca.com 
Top