Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
This study has been terminated.
(The decision to terminate was completely related to efficacy and there were no safety concerns.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00263874
First received: December 8, 2005
Last updated: July 20, 2007
Last verified: July 2007
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Purpose
This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: UK-500,001 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD). |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Secondary Outcome Measures:
- Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
| Estimated Enrollment: | 324 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | September 2006 |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
- Smoking history of at least 10 pack-years
Exclusion Criteria:
- Any significant co-morbid disease
- Use of any maintenance therapy except short acting bronchodilators
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263874
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00263874
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Locations
| Argentina | |
| Pfizer Investigational Site | |
| La Plata, Buenos Aires, Argentina, C1904AGP | |
| Pfizer Investigational Site | |
| Vicente Lopez, Buenos Aires, Argentina, 1602 | |
| Pfizer Investigational Site | |
| Rosario, Santa Fé, Argentina, 2000 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, 1426 | |
| Pfizer Investigational Site | |
| Buenos Aires, Argentina, C1425DQU | |
| Australia, New South Wales | |
| Pfizer Investigational Site | |
| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Victoria | |
| Pfizer Investigational Site | |
| Clayton, Victoria, Australia, 3168a | |
| Australia, Western Australia | |
| Pfizer Investigational Site | |
| Nedlands, Western Australia, Australia, 6009 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T1Y 6J4 | |
| Pfizer Investigational Site | |
| Red Deer, Alberta, Canada, T4N 6V7 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 7500691 | |
| Pfizer Investigational Site | |
| Providencia, Santiago, Chile, 7500691 | |
| Pfizer Investigational Site | |
| ValparaÃso, Chile, 2381594 | |
| Croatia | |
| Pfizer Investigational Site | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Olomouc, Czech Republic, 775 20 | |
| Pfizer Investigational Site | |
| Ostrava-Poruba, Czech Republic, 708 52 | |
| Pfizer Investigational Site | |
| Praha 5, Czech Republic, 150 06 | |
| Pfizer Investigational Site | |
| Tabor, Czech Republic, 390 03 | |
| Hungary | |
| Pfizer Investigational Site | |
| Debrecen, Hungary, 4004 | |
| Pfizer Investigational Site | |
| Torokbalint, Hungary, 2045 | |
| Pfizer Investigational Site | |
| Veszprem, Hungary, 8200 | |
| Singapore | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 308433 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 529889 | |
| Spain | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | |
| Madrid, Spain, 28046 | |
| United Kingdom | |
| Pfizer Investigational Site | |
| Manchester, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00263874 History of Changes |
| Other Study ID Numbers: | A5641009 |
| Study First Received: | December 8, 2005 |
| Last Updated: | July 20, 2007 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Chronic Disease Respiratory Tract Diseases |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on September 28, 2016