Status:
COMPLETED
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
RTI Health Solutions
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this study is to evaluate the potential cardiovascular safety concerns and all-cause mortality described in the risk management plan for aclidinium bromide, through sequential, nested c...
Detailed Description
This is a post-authorisation safety study (PASS) of new users of aclidinium bromide, fixed dose aclidinium bromide/formoterol fumarate dihydrate, and other inhaled medications frequently used by patie...
Eligibility Criteria
Inclusion
- Have at least 1 year of enrolment in the electronic database. In the CPRD, only patients with permanent registration status in "up to standard" participant general practices will be included in the cohort.
- Be aged 40 years or older.
- Have a recorded diagnosis of COPD.
- Have not been prescribed a study medication of interest during the 6 months before the date of the first prescription for that specific study medication.
Exclusion
- Patients with cancer or other serious, non-cardiovascular, life-threatening conditions or indicators of severe comorbidity will be excluded from the study cohort.
- Subjects who will be potentially excluded are those with the following conditions recorded in the database at any time before the date of cohort entry: cancer, HIV, respiratory failure, end-stage renal disease or dialysis, organ transplantation, drug or alcohol abuse, coma, congenital abnormalities of the heart or great arteries.
Key Trial Info
Start Date :
March 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
26839 Patients enrolled
Trial Details
Trial ID
NCT03290287
Start Date
March 1 2017
End Date
June 30 2022
Last Update
January 31 2023
Active Locations (1)
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1
Clinical Practice Research Datalink
London, United Kingdom