A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD)
Tracking Information
Start Date ICMJE | January 2008 |
---|---|
Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 9, 2008) |
|
Original Primary Outcome Measures ICMJE (submitted: November 15, 2007) |
|
Change History | Complete list of historical versions of study NCT00559910 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 9, 2008) |
|
Original Secondary Outcome Measures ICMJE (submitted: November 15, 2007) |
|
Descriptive Information
Brief Title ICMJE | A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD). |
---|---|
Official Title ICMJE | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD). |
Brief Summary | PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD. |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Chronic Obstructive Pulmonary Disease |
Intervention ICMJE |
|
Study Arms / Comparison Groups |
|
Recruitment Information
Estimated Enrollment ICMJE | 256 | ||||
---|---|---|---|---|---|
Estimated Completion Date | January 2010 | ||||
Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||
Gender | Both | ||||
Ages | 40 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
| ||||
Location Countries ICMJE | Argentina, Australia, Canada, Chile, Czech Republic, France, Greece, Hungary, Korea, Republic of, Netherlands, Russian Federation, South Africa, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00559910 | ||||
---|---|---|---|---|---|
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A6631011 | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
| ||||
Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/