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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 605 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01044459
The ClinicalTrials.gov registry entry for NCT01044459 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 605 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 Aclidinium Bromide 200 µg is the first listed.
NCT01044459 reports 0 study locations.
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.
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