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NCT01572792 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 921
- Enrollment target
NCT01572792 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 921 participants.
The verdict
NCT01572792, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 921 participants
- Enrollment target
Study Summary
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
Interventions
- DRUG Placebo
- DRUG Formoterol Fumarate
- DRUG Aclidinium bromide
- DRUG Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 921 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01572792
The ClinicalTrials.gov registry entry for NCT01572792 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 921 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 4 interventions - of which Placebo is the first listed.
NCT01572792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01572792 about?
NCT01572792 is a clinical study titled "Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (CO...
What is the current status of trial NCT01572792?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 921 participants. The study started on 2012-04. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01572792?
The interventions under investigation include: Placebo (DRUG), Formoterol Fumarate (DRUG), Aclidinium bromide (DRUG), Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) (DRUG).
Who is sponsoring clinical trial NCT01572792?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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