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NCT01045161 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 544
- Enrollment target
NCT01045161: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01045161 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 544 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01045161, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 544 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.
Primary Outcome
Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Interventions
- DRUG Placebo
- DRUG Aclidinium bromide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 544 participants |
| Start Date | 2009-03 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
What the finished NCT01045161 record still lists
NCT01045161 is an interventional study that assigns participants to a tested intervention. The registered 544 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01045161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01045161 about?
NCT01045161 is a clinical study titled "Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)". The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week ...
What is the current status of trial NCT01045161?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 544 participants. The study started on 2009-03. Estimated completion is 2011-06.
What interventions are being tested in trial NCT01045161?
The interventions under investigation include: Placebo (DRUG), Aclidinium bromide (DRUG).
Who is sponsoring clinical trial NCT01045161?
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 NCT01045161's enrollment target sits among peer trials
544 691st of 2000 higher than 1,307 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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