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NCT00606684 · ClinicalTrials.gov registry record · Phase 2
A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 602
- Enrollment target
- 20
- Study locations
NCT00606684: Completed Phase 2 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT00606684 is a Phase 2 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 602 participants, below the 1,036-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00606684, a Phase 2 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 602 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)
Primary Outcome
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours aft
Conditions Studied
Interventions
- DRUG GW642444 6.25
- DRUG GW642444 3mcg
- DRUG GW642444 12.5mcg
- DRUG GW642444 25mcg
- DRUG GW642444 50mcg
Study Locations (20)
California
- GSK Investigational Site - Fullerton
- GSK Investigational Site - Lakewood
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Rancho Mirage
- GSK Investigational Site - Sepuldeva
- GSK Investigational Site - Upland
Florida
- GSK Investigational Site - Brandon
- GSK Investigational Site - DeLand
- GSK Investigational Site - Miami
- GSK Investigational Site - Tampa
Alabama
- GSK Investigational Site - Florence
- GSK Investigational Site - Jasper
- GSK Investigational Site - Montgomery
Indiana
- GSK Investigational Site - Carmel
- GSK Investigational Site - Elkhart
- GSK Investigational Site - New Albany
Louisiana
- GSK Investigational Site - Lafayette
- GSK Investigational Site - Sunset
Delaware
- GSK Investigational Site - Newark
Georgia
- GSK Investigational Site - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 602 participants |
| Start Date | 2008-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
What the finished NCT00606684 record still lists
NCT00606684 is an interventional study that assigns participants to a tested intervention. The registered 602 participants enrollment target is mid-sized for trials with a published cap, below the 1,036-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 5 interventions - of which GW642444 6.25 is the first listed.
NCT00606684 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT00606684 about?
NCT00606684 is a clinical study titled "A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)". This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)
What is the current status of trial NCT00606684?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 602 participants. The study started on 2008-02. Estimated completion is 2008-10.
What conditions does trial NCT00606684 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT00606684?
The interventions under investigation include: GW642444 6.25 (DRUG), GW642444 3mcg (DRUG), GW642444 12.5mcg (DRUG), GW642444 25mcg (DRUG), GW642444 50mcg (DRUG).
Who is sponsoring clinical trial NCT00606684?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00606684 being conducted?
This trial has 20 study locations across Alabama, California, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00606684's enrollment target sits among peer trials
602 25th of 74 higher than 50 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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.
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