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Trial record 1 of 1 for:    NCT00163098
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A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00163098
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : October 13, 2006
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 13, 2005
Last Update Posted Date October 13, 2006
Study Start Date  ICMJE December 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Effect on exercise tolerance
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00163098 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2005)
Effect on lung function and quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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
 (submitted: September 11, 2005)
136
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • GOLD criteria 2 to 4
  • 10 pack year history of smoking

Exclusion Criteria:

  • Women of child bearing potential
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Study Director: Pfizer CT.gov Call Center Pfizer
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