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NCT01313650 · ClinicalTrials.gov registry record · Phase 3
A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,538
- Enrollment target
NCT01313650: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01313650 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,538 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313650, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,538 participants
- Enrollment target
Study Summary
This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is
Interventions
- DRUG Placebo
- DRUG 62.5/25mcg
- DRUG 62.5mcg
- DRUG 25mcg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,538 participants |
| Start Date | 2011-03-01 |
| Est. Completion | 2012-04-05 |
| Phase | Phase 3 |
What the finished NCT01313650 record still lists
NCT01313650 is an interventional study that assigns participants to a tested intervention. Its 1,538 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01313650 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01313650 about?
NCT01313650 is a clinical study titled "A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD". This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inh...
What is the current status of trial NCT01313650?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,538 participants. The study started on 2011-03-01. Estimated completion is 2012-04-05.
What interventions are being tested in trial NCT01313650?
The interventions under investigation include: Placebo (DRUG), 62.5/25mcg (DRUG), 62.5mcg (DRUG), 25mcg (DRUG).
Who is sponsoring clinical trial NCT01313650?
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 NCT01313650's enrollment target sits among peer trials
1,538 151st of 2000 higher than 1,849 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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