Trials / Completed
CompletedNCT03290287
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints
Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints: Common Study Protocol
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 26,839 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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 case-control studies for each endpoint of interest
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 patients with COPD The plan is for the PASS study to be conducted on one population-based automated health database; the initial candidate database is the CRPD in the United Kingdom.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Aclidinium bromide | Administered as monotherapy, concomitant with formoterol not in fixed-dose combination, or fixed-dose aclidinium/formoterol |
| DRUG | Other COPD medication | Users of the following COPD medications: Tiotropium Other long-acting anticholinergic (LAMAs): glycopyrronium bromide, umeclidinium LABA: formoterol, salmeterol, indacaterol LABA/ICS (LABA in fixed-dose combinations with ICS): formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone, and vilanterol/fluticasone. LAMA/LABA (approved or under regulatory review or in development): glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol |
Timeline
- Start date
- 2017-03-01
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2017-09-21
- Last updated
- 2023-01-31
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT03290287. Inclusion in this directory is not an endorsement.