United States Post-Marketing Observational Cardiovascular Safety Study in Patients taking Naloxegol (Naloxegol US Post-Market Requirement CV Safety)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25981
• EU PAS number:
  EUPAS18201
• Study ID:
  25981
• Official title and acronym:
  United States Post-Marketing Observational Cardiovascular Safety Study in Patients taking Naloxegol (Naloxegol US Post-Market Requirement CV Safety)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The 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.
• Study status:
  Ongoing

Research institution and networks

Institutions

Evidera

United Kingdom

HealthCore

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

Study timelines

Date when funding contract was signed

Planned: 13/10/2015

Actual: 13/10/2015

Study start date

Planned: 01/12/2015

Actual: 01/12/2015

Data analysis start date

Planned: 01/06/2016

Actual: 01/06/2016

Date of interim report, if expected

Planned: 30/06/2018

Actual: 23/05/2018

Date of final study report

Planned: 31/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

D3820R00008-clinical-study-protocol-25Sep2015 Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D3820R00008