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NCT01049360 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
NCT01049360 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 128 participants.
The verdict
NCT01049360, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium bromide and formoterol fumarate, all administered twice a day (BID) in patients with stable, moderate to severe chronic obstructive pulmonary disease (COPD) beginning with a 2-week run-in period and with a 7-10 day washout each between treatment period.
Interventions
- DRUG Placebo
- DRUG Aclidinium 400 μg / Formoterol 12 μg
- DRUG Aclidinium 400 μg / Formoterol 6 μg
- DRUG Aclidinium 400 μg
- DRUG Formoterol 12 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2009-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01049360
The ClinicalTrials.gov registry entry for NCT01049360 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 128 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 5 interventions - of which Placebo is the first listed.
NCT01049360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01049360 about?
NCT01049360 is a clinical study titled "Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo". The purpose of this study is to evaluate the efficacy of this multicenter, randomized, double-blind, placebo-controlled, 4-period, incomplete-block crossover, dose-ranging study comparing 2 fixed dose combinations (FDCs) of aclidinium bromide with formoterol fumarate or with placebo, aclidinium brom...
What is the current status of trial NCT01049360?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2009-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT01049360?
The interventions under investigation include: Placebo (DRUG), Aclidinium 400 μg / Formoterol 12 μg (DRUG), Aclidinium 400 μg / Formoterol 6 μg (DRUG), Aclidinium 400 μg (DRUG), Formoterol 12 μg (DRUG).
Who is sponsoring clinical trial NCT01049360?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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