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NCT01316887 · ClinicalTrials.gov registry record · Phase 3
A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 563
- Enrollment target
NCT01316887 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 563 participants.
The verdict
NCT01316887, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 563 participants
- Enrollment target
Study Summary
The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.
Interventions
- DRUG 125/25 mcg once-daily GSK573719/GW642444
- DRUG 125mcg once-daily GSK573719
- DRUG Placebo once-daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 563 participants |
| Start Date | 2011-01-01 |
| Est. Completion | 2012-07-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01316887
The ClinicalTrials.gov registry entry for NCT01316887 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 563 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 125/25 mcg once-daily GSK573719/GW642444 is the first listed.
NCT01316887 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01316887 about?
NCT01316887 is a clinical study titled "A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term...
What is the current status of trial NCT01316887?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 563 participants. The study started on 2011-01-01. Estimated completion is 2012-07-21.
What interventions are being tested in trial NCT01316887?
The interventions under investigation include: 125/25 mcg once-daily GSK573719/GW642444 (DRUG), 125mcg once-daily GSK573719 (DRUG), Placebo once-daily (DRUG).
Who is sponsoring clinical trial NCT01316887?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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