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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 544 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01045161
The ClinicalTrials.gov registry entry for NCT01045161 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 544 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01045161 reports 0 study locations.
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.
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