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NCT01966107 · ClinicalTrials.gov registry record · Phase 4
Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
A Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 4
- Development phase
- 3,635
- Enrollment target
- 20
- Study locations
NCT01966107: Completed Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD, sponsored by AstraZeneca.
NCT01966107 is a Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD that has completed, run by AstraZeneca. The registered enrollment target is 3,635 participants, above the 1,712-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (112% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01966107, a Phase 4 study of Chronic Obstructive Pulmonary Disease and COPD, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 3,635 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Primary Outcome
The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aclidinium Bromide
Study Locations (20)
Alabama
- Research Site - Birmingham
- Research Site - Birmingham
- Research Site - Birmingham
- Research Site - Birmingham
- Research Site - Birmingham
- Research Site - Florence
- Research Site - Foley
- Research Site - Huntsville
- Research Site - Jasper
- Research Site - Mobile
- Research Site - Tuscaloosa
Arizona
- Research Site - Chandler
- Research Site - Glendale
- Research Site - Mesa
- Research Site - Peoria
- Research Site - Phoenix
- Research Site - Phoenix
- Research Site - Phoenix
- Research Site - Phoenix
- Research Site - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,635 participants |
| Start Date | 2013-10-16 |
| Est. Completion | 2017-09-21 |
| Phase | Phase 4 |
What the finished NCT01966107 record still lists
NCT01966107 is an interventional study that assigns participants to a tested intervention. Its 3,635 participants enrollment target places it among the larger protocols in the corpus, above the 1,712-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (112% higher).
The record links to 3 conditions, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01966107 names 20 study sites across 2 states, led by Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT01966107 about?
NCT01966107 is a clinical study titled "Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.". The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomiz...
What is the current status of trial NCT01966107?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 3,635 participants. The study started on 2013-10-16. Estimated completion is 2017-09-21.
What conditions does trial NCT01966107 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease, COPD, Moderate to Very Severe COPD.
What interventions are being tested in trial NCT01966107?
The interventions under investigation include: Placebo (DRUG), Aclidinium Bromide (DRUG).
Who is sponsoring clinical trial NCT01966107?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01966107 being conducted?
This trial has 20 study locations across Alabama, Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01966107's enrollment target sits among peer trials
3,635 3rd of 86 higher than 84 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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