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NCT01572792 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 921
- Enrollment target
NCT01572792: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01572792 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 921 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01572792, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 921 participants
- Enrollment target
Study Summary
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
Primary Outcome
For each safety parameter, the last assessment made before the first dose of investigational product in the lead-in study (LAC MD-31) was used as the baseline for all analyses of that safety parameter in this extension study
Interventions
- DRUG Placebo
- DRUG Formoterol Fumarate
- DRUG Aclidinium bromide
- DRUG Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 921 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
What the finished NCT01572792 record still lists
NCT01572792 is an interventional study that assigns participants to a tested intervention. The registered 921 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01572792 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01572792 about?
NCT01572792 is a clinical study titled "Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (CO...
What is the current status of trial NCT01572792?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 921 participants. The study started on 2012-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01572792?
The interventions under investigation include: Placebo (DRUG), Formoterol Fumarate (DRUG), Aclidinium bromide (DRUG), Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) (DRUG).
Who is sponsoring clinical trial NCT01572792?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01572792's enrollment target sits among peer trials
921 345th of 2000 higher than 1,656 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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