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NCT01044459 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 605
- Enrollment target
NCT01044459: Completed Phase 3 study, sponsored by AstraZeneca.
NCT01044459 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 605 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01044459, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 605 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
Primary Outcome
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
Interventions
- DRUG Aclidinium Bromide 200 µg
- DRUG Aclidinium Bromide 400 µg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 605 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT01044459 record still lists
NCT01044459 is an interventional study that assigns participants to a tested intervention. The registered 605 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 (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Aclidinium Bromide 200 µg is the first listed.
NCT01044459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01044459 about?
NCT01044459 is a clinical study titled "Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)". The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment perio...
What is the current status of trial NCT01044459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 605 participants. The study started on 2009-11. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01044459?
The interventions under investigation include: Aclidinium Bromide 200 µg (DRUG), Aclidinium Bromide 400 µg (DRUG).
Who is sponsoring clinical trial NCT01044459?
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 NCT01044459's enrollment target sits among peer trials
605 607th of 2000 higher than 1,394 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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