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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263874
Hide Study Locations
Hide Study LocationsLocations
| 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, 529889 | |
| Pfizer Investigational Site | |
| Singapore, Singapore, 308433 | |
| 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:
No publications provided by Pfizer
Additional 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:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013