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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00606684 |
This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)
Condition | Intervention | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: GW642444 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study B2C111045, A Dose-Finding Study of GW642444 Versus Placebo in Patients With COPD. |
Estimated Enrollment: | 576 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects eligible for enrollment in the study must meet all of the following criteria:
Gender: Male or females who are 40 - 80 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of:
Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
The investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study. However, the following predetermined ECG abnormalities are considered clinically significant and will result in exclusion of a subject:
Additional Medications: The following medications are not permitted during this study and must not have been taken for the indicated times prior to Visit 1 (See Prohibited Medications): Medication (Required period of time prior to screening visit):
Study Director: | GSK Clinical Trials, M.D. | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | B2C111045 |
Study First Received: | January 18, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00606684 |
Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
COPD GW642444 |
Signs and Symptoms Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |