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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: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01316887 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 563 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with
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 |
What the finished NCT01316887 record still lists
NCT01316887 is an interventional study that assigns participants to a tested intervention. The registered 563 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which 125/25 mcg once-daily GSK573719/GW642444 is the first listed.
NCT01316887 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316887's enrollment target sits among peer trials
563 668th of 2000 higher than 1,332 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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