Study To Assess Efficacy and Safety of Oglemilast in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00671073
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
427 participants
INTERVENTIONAL
2008-05-05
2009-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Oglemilast low dose, oral administration once daily for 12 weeks
Oglemilast
Oglemilast low dose, oral administration, once daily for 12 weeks
2
Oglemilast middle dose, oral administration, once daily for 12 weeks
Oglemilast
Oglemilast middle dose, oral administration, once daily for 12 weeks
3
Oglemilast high dose, oral administration, once daily for 12 weeks.
Oglemilast
Oglemilast high dose, oral administration, once daily for 12 weeks
4
Placebo
Placebo
Placebo, oral administration, once daily for 12 weeks
Interventions
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Oglemilast
Oglemilast low dose, oral administration, once daily for 12 weeks
Placebo
Placebo, oral administration, once daily for 12 weeks
Oglemilast
Oglemilast middle dose, oral administration, once daily for 12 weeks
Oglemilast
Oglemilast high dose, oral administration, once daily for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current or former cigarette smoker
Exclusion Criteria
* Symptoms consistent with a significant asthmatic component (e.g. atopic disease, allergic symptoms)
* Any COPD exacerbations within 30 days prior to study entry or during run-in
* History of chronic or recurrent gastrointestinal disorder associated with bleeding in previous 12 months
* Presence of clinical significant pulmonary disease other than COPD
40 Years
80 Years
ALL
No
Sponsors
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Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Brian T Maurer, MS
Role: STUDY_DIRECTOR
Forest Laboratories
Locations
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Forest Investigative Site
Birmingham, Alabama, United States
Forest Investigative Site
Phoenix, Arizona, United States
Forest Investigative Site
Tucson, Arizona, United States
Forest Investigative Site
Buena Park, California, United States
Forest Investigative Site
Encinitas, California, United States
Forest Investigative Site
Fullerton, California, United States
Forest Investigative Site
Los Angeles, California, United States
Forest Investigative Site
Orange, California, United States
Forest Investigative Site
Rancho Mirage, California, United States
Forest Investigative Site
San Diego, California, United States
Forest Investigative Site
San Diego, California, United States
Forest Investigative Site
Stockton, California, United States
Forest Investigative Site
Centennial, Colorado, United States
Forest Investigative Site WR1
Wheat Ridge, Colorado, United States
Forest Investigative Site WR2
Wheat Ridge, Colorado, United States
Forest Investigative Site
Waterbury, Connecticut, United States
Forest Investigative Site
Fort Lauderdale, Florida, United States
Forest Investigative Site
Miami, Florida, United States
Forest Investigative Site
Miami, Florida, United States
Forest Investigative Site
Ormond Beach, Florida, United States
Forest Investigative Site
Tamarac, Florida, United States
Forest Investigative Site
Skokie, Illinois, United States
Forest Investigative Site
Evansville, Indiana, United States
Forest Investigative Site
North Dartmouth, Massachusetts, United States
Forest Investigative Site
Livonia, Michigan, United States
Forest Investigative Site
Edina, Minnesota, United States
Forest Investigative Site
Minneapolis, Minnesota, United States
Forest Investigative Site
Papillion, Nebraska, United States
Forest Investigative Site
Cherry Hill, New Jersey, United States
Forest Investigative Site
Elmira, New York, United States
Forest Investigative Site
Mineola, New York, United States
Forest Investigative Site
Rochester, New York, United States
Forest Investigative Site
Charlotte, North Carolina, United States
Forest Investigative Site
Cincinnati, Ohio, United States
Forest Investigative Site
Cincinnati, Ohio, United States
Forest Investigative Site
Toledo, Ohio, United States
Forest Investigative Site
Medford, Oregon, United States
Forest Investigative Site
Portland, Oregon, United States
Forest Investigative Site
Bethlehem, Pennsylvania, United States
Forest Investigative Site
Philadelphia, Pennsylvania, United States
Forest Investigative Site
Charleston, South Carolina, United States
Forest Investigative Site
Greenville, South Carolina, United States
Forest Investigative Site
Spartanburg, South Carolina, United States
Forest Investigative Site
El Paso, Texas, United States
Forest Investigative Site
San Antonio, Texas, United States
Forest Investigative Site
Fredericksburg, Virginia, United States
Forest Investigative Site
Tacoma, Washington, United States
Countries
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Other Identifiers
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GRC-MD-50
Identifier Type: -
Identifier Source: org_study_id
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