A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD
NCT00163098
Last updated date
ABOUT THIS STUDY
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance
in patients with COPD
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Chronic Obstructive Pulmonary Disease
Sex
Females and Males
Age
35-75 years
Inclusion Criteria
Show details
- GOLD criteria 2 to 4
- 10 pack year history of smoking
Exclusion Criteria
Show details
- Women of child bearing potential
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD | |||
Official Title ICMJE | 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 | |||
Brief Summary | A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Pulmonary Disease, Chronic Obstructive | |||
Intervention ICMJE | Drug: UK-369,003 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 136 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 35 Years to 75 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Germany, India, United Kingdom | |||
Removed Location Countries | Belgium | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00163098 | |||
Other Study ID Numbers ICMJE | A3711028 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |