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NCT01316913 · ClinicalTrials.gov registry record · Phase 3
24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 872
- Enrollment target
NCT01316913 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 872 participants.
The verdict
NCT01316913, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 872 participants
- Enrollment target
Study Summary
This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 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 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.
Interventions
- DRUG GSK573719/GW642444 125/25
- DRUG GSK573719/GW642444 62.5/25
- DRUG tiotropium bromide
- DRUG GSK573719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 872 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01316913
The ClinicalTrials.gov registry entry for NCT01316913 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 872 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 4 interventions - of which GSK573719/GW642444 125/25 is the first listed.
NCT01316913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01316913 about?
NCT01316913 is a clinical study titled "24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease". This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-dail...
What is the current status of trial NCT01316913?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 872 participants. The study started on 2011-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01316913?
The interventions under investigation include: GSK573719/GW642444 125/25 (DRUG), GSK573719/GW642444 62.5/25 (DRUG), tiotropium bromide (DRUG), GSK573719 (DRUG).
Who is sponsoring clinical trial NCT01316913?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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