A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00163098
First received: September 8, 2005
Last updated: October 12, 2006
Last verified: October 2006
  Purpose

A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: UK-369,003
Phase 1
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 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Effect on exercise tolerance

Secondary Outcome Measures:
  • Effect on lung function and quality of life

Estimated Enrollment: 136
Study Start Date: December 2004
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Women of child bearing potential
  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: NCT00163098

Locations
Argentina
Pfizer Investigational Site
Unknown, Buenos Aires, Argentina
Pfizer Investigational Site
Ciudad de Cordoba, Cordoba, Argentina, CP 5016
Pfizer Investigational Site
San Miguel de Tucuman, Pcia de Tucuman, Argentina
Pfizer Investigational Site
San Miguel de Tucuman, Pcia de Tucuman, Argentina, 4000
Pfizer Investigational Site
Rosario, Santa Fé, Argentina, 2000
Pfizer Investigational Site
Buenos Aires, Argentina, 1272
Pfizer Investigational Site
Buenos Aires, Argentina, 1427
Pfizer Investigational Site
Ciudad de Beurnos Aires, Argentina, C1425DQi
Pfizer Investigational Site
Ciudad de Buenos Aires, Argentina, C1115AAB
Pfizer Investigational Site
Ciudad de Buenos Aires, Argentina, C1416DRV
Pfizer Investigational Site
Ciudad de Buenos Aires,, Argentina, (C1425DTG)
Pfizer Investigational Site
Provincia de Buenos Aires, Argentina, (1605)
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Pfizer Investigational Site
Chermside,, Queensland, Australia, 4032
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Pfizer Investigational Site
Perth, Western Australia, Australia, 6000
Germany
Pfizer Investigational Site
Giessen, Germany, 35392
Pfizer Investigational Site
Greifestein, Germany, 35753
India
Pfizer Investigational Site
Cochin, Kerala, India, 682026
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400016
Pfizer Investigational Site
Pune, Maharashtra, India, 411 019
Pfizer Investigational Site
Chennai, Tamilnadu, India, 600116
Pfizer Investigational Site
Vellore, Tamilnadu, India, 632002
United Kingdom
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, United Kingdom, CB3 8RE
Pfizer Investigational Site
Glasgow, United Kingdom, G11 6NT
Pfizer Investigational Site
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00163098     History of Changes
Other Study ID Numbers: A3711028
Study First Received: September 8, 2005
Last Updated: October 12, 2006
Health Authority: Germany: Ethics Commision

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 July 23, 2014