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NCT01437397 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,692
- Enrollment target
NCT01437397 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 1,692 participants.
The verdict
NCT01437397, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,692 participants
- Enrollment target
Study Summary
The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.
Interventions
- DRUG Placebo
- DRUG Formoterol Fumarate
- DRUG Aclidinium Bromide
- DRUG Aclidinium Bromide/Formoterol Fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,692 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01437397
The ClinicalTrials.gov registry entry for NCT01437397 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,692 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.
NCT01437397 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01437397 about?
NCT01437397 is a clinical study titled "Efficacy, Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tole...
What is the current status of trial NCT01437397?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,692 participants. The study started on 2011-09. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01437397?
The interventions under investigation include: Placebo (DRUG), Formoterol Fumarate (DRUG), Aclidinium Bromide (DRUG), Aclidinium Bromide/Formoterol Fumarate (DRUG).
Who is sponsoring clinical trial NCT01437397?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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