Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Multi-Centre, Multinational, Randomized, Double-Blind, Placebo Controlled, Proof Of Concept Trial To Assess The Effects Of A Subject-Optimized Dose Of UK-369,003 On Exercise Capacity In Subjects With Chronic Obstructive Pulmonary Disease
| Verified date | October 2006 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commision |
| Study type | Interventional |
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD
| Status | Completed |
| Enrollment | 136 |
| Est. completion date | December 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - GOLD criteria 2 to 4 - 10 pack year history of smoking Exclusion Criteria: - Women of child bearing potential |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Ciudad de Beurnos Aires | |
| Argentina | Pfizer Investigational Site | Ciudad de Buenos Aires | |
| Argentina | Pfizer Investigational Site | Ciudad de Buenos Aires | |
| Argentina | Pfizer Investigational Site | Ciudad de Buenos Aires, | |
| Argentina | Pfizer Investigational Site | Ciudad de Cordoba | Cordoba |
| Argentina | Pfizer Investigational Site | Provincia de Buenos Aires | |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fé |
| Argentina | Pfizer Investigational Site | San Miguel de Tucuman | Pcia de Tucuman |
| Argentina | Pfizer Investigational Site | San Miguel de Tucuman | Pcia de Tucuman |
| Argentina | Pfizer Investigational Site | Unknown | Buenos Aires |
| Australia | Pfizer Investigational Site | Adelaide | South Australia |
| Australia | Pfizer Investigational Site | Camperdown | New South Wales |
| Australia | Pfizer Investigational Site | Chermside, | Queensland |
| Australia | Pfizer Investigational Site | Darlinghurst | New South Wales |
| Australia | Pfizer Investigational Site | Melbourne | Victoria |
| Australia | Pfizer Investigational Site | Perth | Western Australia |
| Germany | Pfizer Investigational Site | Giessen | |
| Germany | Pfizer Investigational Site | Greifestein | |
| India | Pfizer Investigational Site | Chennai | Tamilnadu |
| India | Pfizer Investigational Site | Cochin | Kerala |
| India | Pfizer Investigational Site | Mumbai | Maharashtra |
| India | Pfizer Investigational Site | Pune | Maharashtra |
| India | Pfizer Investigational Site | Vellore | Tamilnadu |
| United Kingdom | Pfizer Investigational Site | Glasgow | |
| United Kingdom | Pfizer Investigational Site | Newcastle Upon Tyne | |
| United Kingdom | Pfizer Investigational Site | Papworth Everard | Cambridgeshire |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Argentina, Australia, Germany, India, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect on exercise tolerance | |||
| Secondary | Effect on lung function and quality of life |
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